13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

March 21, 2011 updated by: University of Oxford

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Children's Vaccine Centre, University of Bristol
      • London, United Kingdom
        • St George's Vaccine Institute, University of London
      • Oxford, United Kingdom, OX3 7LJ
        • Oxford Vaccine Group, Dept Paediatrics, University of Oxford
      • Southampton, United Kingdom
        • Wellcome Trust Clinical Research Facility, University of Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PCV13
Initial vaccination with PCV13
Biological: PCV13
Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
Other Names:
  • 13-valent pneumococcal conjugate vaccine
Experimental: PCV7
Initial intervention with PCV7
Biological: PCV13
Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
Other Names:
  • 13-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of PCV13 booster vaccinations
Time Frame: 1 month
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess IgG concentrations for PCV13 serotypes in children immunised with PCV7 and PCV13
Time Frame: 1 month
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
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
1 month
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
1 month
To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination.
Time Frame: 1 month
1 month
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
1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southampton
University of Bristol
University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009/04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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