Safety, Tolerability and Immunogenicity of 13 valent Pneumococcal Conjugate Vaccine (13vPnC) in children with Sickle Cell Disease from 6 to 18 years of age.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2009-011396-77-GB
• Date of registration: 31/07/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals Inc. (a Pfizer Company)
• Public title: Safety, Tolerability and Immunogenicity of 13 valent Pneumococcal Conjugate Vaccine (13vPnC) in children with Sickle Cell Disease from 6 to 18 years of age.
• Scientific title: A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23-valent Pneumococcal Polysaccharide Vaccine
• Date of first enrolment: 28/09/2009
• Target sample size: 140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011396-77
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Egypt, France, Italy, Lebanon, Saudi Arabia, United Kingdom

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1.Male or female subject between the ages of =6 to <18 years.
2.Diagnosis of SCD by hemoglobin electrophoresis or polymerase chain reaction (PCR); (HbSS, HbSC, HbSD, HbSE, HbSß-thal).
3.Documentation to show 23vPS vaccination at least 6 months prior to enrollment.
4.Available for entire study period and whose parent/legal guardian can be reached by telephone.
5.Subject and/or parent/legal guardian must be able to complete all relevant study procedures during study participation.
6.Negative urine pregnancy test for female subjects who are postmenarche.
7.All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last vaccination.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
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.History of culture-proven invasive disease caused by S. pneumoniae within the last year.
2.Subject has/had a major illness or condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in, and completion of the study.
3.Subject has/had a major illness or condition that, in the investigator’s judgment, could preclude the evaluation of the subject’s response to vaccination.
4.History of hematopoietic stem cell transplantation.
5.Previous vaccination with PnC vaccine.
6.Has a dose of 23vPS recommended between enrollment and the blood draw at visit 6.
7.Previous anaphylactic reaction to any vaccine or vaccine-related component.
8.Contraindication to vaccination with pneumococcal conjugate vaccine.
9.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
10.Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
11.Known or suspected immune deficiency or suppression.
12.Pregnant or breast feeding female.
13.Participation in another investigational trial from 28 days before enrollment until the end of the study. (Note: participation in purely observational studies is acceptable.)
14.Subject is a direct descendant (child or grandchild) of a member of site study personnel or is study personnel.
15.Active Hepatitis C infection requiring interferon or ribavirin treatment.


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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Pneumococcal infection
MedDRA version: 14.1 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations

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-

Primary Outcome(s)

Main Objective: To evaluate the immune response 1 month after 2 doses of 13vPnC given 6 months apart compared to 1 month after 1 dose of 13vPnC as measured by fold rise in serotype specific IgG geometric mean concentrations (GMCs) in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.

Secondary Objective: To evaluate the immune response 1 month after 2 doses of 13vPnC given 6 months apart compared to 1 month after 1 dose of 13vPnC as measured by serotype-specific IgG GMCs in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.
To describe the immune response 1 year after 2 doses of 13vPnC given 6 months apart as measured by the serotype-specific IgG GMCs in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.

Primary end point(s): The geometric mean fold rise (GMFR) in IgG is the primary analysis endpoint following dose 2 relative to dose 1 for each serotype.

Timepoint(s) of evaluation of this end point: June 2012

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: March 2013

Secondary end point(s): To describe the immune response 1 year after 2 doses of 13vPnC given 6 months apart as measured by the serotype-specific opsonophagocytic activity (OPA) GMTs and IgG GMCs in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.
To describe the immune response 1 year after 2 doses of 13vPnC given 6 months apart as measured by the serotype-specific IgG GMCs in children with SCD who have previously been vaccinated with at least 1 dose of 23vPS.

Secondary ID(s)

2009-011396-77-FR

B1851013(6096A1-3014-WW)

Source(s) of Monetary Support

Wyeth Pharmaceuticals Inc. (a Pfizer Company)

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 01/08/2015
• Date Completed: 28/03/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011396-77/results