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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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25 November 2019 |
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Main ID: |
EUCTR2005-005130-12-GB |
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Date of registration:
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20/04/2006 |
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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, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom - N/A
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Scientific title:
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A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom - N/A |
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Date of first enrolment:
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03/08/2006 |
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Target sample size:
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600 |
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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:2005-005130-12 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
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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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged 2 months (42 to 98 days) at time of enrollment.
2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
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. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccine.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S.pneumonia, Neisseria meningitidis,or Haemophilus influenzae type b (Hib).
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including Hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis).
11. Participation in another investigational study. Participation in purely observational studies is acceptable.
12. Infant who is a direct descendant (child, grandchild) of the study site personnel.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Healthy infants
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Intervention(s)
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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 4
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 3
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 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/m
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Primary Outcome(s)
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Primary end point(s): See primary objectives
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Main Objective: - To demonstrate that the immune response induced by NeisVac-C or Pediacel given with 13vPnC is noninferior to the immune response induced by NeisVac-C or Pediacel given with 7vPnC when measured 1 month after the infant series. The immune response to the meningococcal C antigen will be assessed using a serum bactericidal assay (SBA). The immune responses to the following antigens in Pediacel will be assessed: acellular pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin [PRN] and fimbrial agglutinogens ) and Haemophilus influenzae type b (Hib).
Safety objective:
- To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local injection site reactions, systemic events, and adverse events (AEs).
13vPnC immunogenicity objectives:
- To assess the immune response to 13vPnC 1 month after a 2-dose infant series and before and 1 month after the toddler dose as measured by serum immunoglobulin G (IgG) responses.
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Secondary Objective: - To assess the immune responses induced by Menitorix given with 13vPnC relative to the immune responses induced by Menitorix given with 7vPnC when measured 1 month after the toddler dose (Hib and meningococcal C). ·
- To assess the immune responses induced by NeisVac-C given with 13vPnC to the immune responses induced by NeisVac-C given with 7vPnC when measured before the toddler dose (meningococcal C).·
- To assess the immune response induced by Pediacel given with 13vPnC to the immune response induced by Pediacel given with 7vPnC at alternative cutoff levels when measured 1 month after the infant series (Hib).·
- To assess the immune responses induced by Menitorix given with 13vPnC to the immune responses induced by Menitorix given with 7vPnC at alternative cutoff levels when measured 1 month after the toddler dose (Hib).
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Secondary ID(s)
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6096A1-007
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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