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13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

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ClinicalTrials.gov Identifier: NCT01095471
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 22, 2011
Sponsor:
Collaborators:
University of Bristol
University of Southampton
University of London
Information provided by:
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: PCV13 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCV13
Initial vaccination with PCV13
Biological: PCV13
Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
Other Name: 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 Name: 13-valent pneumococcal conjugate vaccine




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]
  4. To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination. [ Time Frame: 1 month ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   39 Months to 46 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095471


Locations
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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, OX3 7LJ
Wellcome Trust Clinical Research Facility, University of Southampton
Southampton, United Kingdom
Sponsors and Collaborators
University of Oxford
University of Bristol
University of Southampton
University of London
Investigators
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Principal Investigator: Andrew Pollard, FRCPCH, PhD University of Oxford, Department of Paediatrics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Andrew Pollard, Chief Investigator, University of Oxford
ClinicalTrials.gov Identifier: NCT01095471     History of Changes
Other Study ID Numbers: 2009/04
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011
Keywords provided by University of Oxford:
7 valent Pneumococcal conjugate vaccine
13 valent Pneumococcal conjugate vaccine
PCV13
PCV7
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs