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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.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2008-006194-33-IS
Date of registration:	16/02/2009
Prospective Registration:	Yes
Primary sponsor:	Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Public title:	Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY) - REPLAY
Scientific title:	Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY) - REPLAY
Date of first enrolment:	07/04/2009
Target sample size:	224
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006194-33
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes 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 Other specify the comparator: No comparator
Phase:

Countries of recruitment
Iceland

Contacts

Name:
Address:
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Affiliation:

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Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
1. Fully vaccinated children who participated in the D139-P506 study and received a booster dose of either PPV23 or PCV per the original protocol
2. Subjects must be in good health as determined by medical history, physical examination and clinical judgment
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:
1. Known or suspected hypersensitivity to any component of PCV7 or PCV13
2. History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site)
3. Any known or suspected disease or dysfunction of the immune system, including but not limited to:
• HIV infection
• Malignancy
• Receipt of immunosuppressive therapy
• Sickle cell hemoglobinopathy
• Diabetes
4. Concomitant vaccination during study period (see Concomitant Treatment)
5. Receipt of immune globulin within the past 3 months
6. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response
7. Receipt of either PPV23 or PCV7 since the completion of the D139-P506 study

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Invasive pneumococcal disease
MedDRA version: 9.1 Level: LLT Classification code 10061353 Term: Pneumococcal infection

Intervention(s)

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 Polysaccharide Serotype 19A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal Polysaccharide Serotype 19F
Concentration

Primary Outcome(s)

Main Objective: To characterize the immune response by ELISA and OPA at approximately one month after vaccination to a single dose of PCV13 challenge in children vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23

Secondary Objective: • To describe the immune response by avidity assay to a single dose of PCV13 challenge in children previously vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23
• To describe the kinetics of the immune response over the entire observation period after a single dose of PCV13 challenge in children previously vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23
• To evaluate the safety profile of PCV13 as measured by the occurrence of serious adverse events (SAEs), adverse events (AEs), and solicited local and systemic reactions in the two groups.

Primary end point(s): The coprimary endpoints for each of the pneumococcal serotypes are the proportions of subjects achieving a serotype-specific IgG antibody concentration 0.35µg/mL by ELISA and a titre =1:8 by OPA.

Secondary Outcome(s)

Secondary ID(s)

6096A1-3013-EU

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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