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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2009-015321-37-FR |
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Date of registration:
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17/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
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Scientific title:
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A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine |
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Date of first enrolment:
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22/02/2010 |
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Target sample size:
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500 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015321-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Subjects who received all 4 assigned doses of the PnC vaccine as randomized and completed study 6096A1-008-EU.
• Subjects are at least 24 months posttoddler dose and at least 3 years of age at visit 1.
• Healthy as determined by medical history, physical examination, and judgment of the investigator.
• Available for the entire study period and his or her parents/legal guardians must be able to complete all relevant study procedures during study participation and can be reached by telephone.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Vaccination with any licensed or investigational pneumococcal vaccine since completion of the 6096A1 008-EU study.
• History of culture-proven invasive disease caused by S pneumoniae since the completion of study 6096A1 008-EU.
• 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 since participation in study 6096A1-008-EU.
• Major known congenital malformation or serious chronic disorder.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure), or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
• Receipt of any blood products, including immunoglobulin, within 90 days before the study.
• Current participation in another investigational or interventional trial. (Note: participation in purely observational studies is acceptable).
• Received any live vaccine within 28 days before administration of the first study vaccine.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Pneumococcal infection
MedDRA version: 12.1
Level: LLT
Classification code 10061353
Term: Pneumococcal infection
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Intervention(s)
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Product Name: 13-valent pneumococcal conjugate vaccine
Product Code: 13vPnC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 1
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 4
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 5
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 6A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 6B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 8.8-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 7F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 9V
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 14
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 18C
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysa
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is the serotype-specific IgG concentration 1 month after the single dose of 13vPnC.
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Main Objective: To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specific (immunoglobulin G) IgG concentrations.
To evaluate the immune response to 13 pneumococcal vaccine serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific IgG concentrations.
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Secondary Objective: To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specific opsonophagocytic activity (OPA).
To evaluate the immune response to 13 pneumococcal vaccine serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific OPA antibody titers.
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Secondary ID(s)
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6096A1-3021-FR
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 22/02/2010
Contact:
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