A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004465-18-SE
• Date of registration: 20/09/2007
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.
• Public title: A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment
• Scientific title: A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment
• Date of first enrolment: 15/11/2007
• Target sample size: 924
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004465-18
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
[1] Male or female adult 70 years of age or older at the time of enrollment.
[2] Documented vaccination with 1 dose of 23vPS at least 5 years before study enrollment.
[3] Determined by medical history, physical examination, and clinical judgment to be eligible for the study. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapya or hospitalization for worsening disease 12 weeks before receipt of the test article, are eligible.
[4] Able to complete an electronic diary (e-diary) and follow study procedures in the opinion of the investigator.
[5] Expected to be available for the duration of the trial (approximately 18 months).
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
[1] History of severe adverse reaction associated with a vaccine.
[2] Receipt of more than one 23vPS dose before study enrollment or any prior pneumococcal conjugate vaccine.
[3] Receipt of any vaccine within 30 days before test article administration, except influenza vaccine.
[4] Vaccination with a diphtheria-containing vaccine within 6 months before test article administration or anticipated receipt before study completion.
[5] Documented S pneumoniae infection within the past 5 years.
[6] Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids, eg, for cancer, HIV or autoimmune disease. If systemic corticosteroids have been administered short term for treatment of an acute illness, subjects should be excluded from the study until corticosteroid therapy has been discontinued for at least 30 days.
[7] Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator’s opinion precludes the subject from participating in the study.
[8] Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care. An ambulatory subject, who is a resident of a retirement home or village, is eligible for the trial.
[9] Evidence of dementia or other severe cognitive impairment based on a Mini-Mental State Examination (MMSE) score of less than or equal to 21.
[10] Poor or missing eyesight, requiring third-party support to read.
[11] Receipt of any blood products, including immunoglobulin, within 6 months before test article administration or anticipated receipt before study completion.
[12] In the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass or unable to grade limitation of arm movement that would interfere with the evaluation of the study objectives.
[13] Currently on anticoagulant therapy or a history of bleeding diathesis that would contraindicate intramuscular (IM) injection.
[14] Intent to receive any other investigational vaccine or agent from 1 month (30 days) before enrollment until the conclusion of the study.
[15] Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.


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

Health Condition(s) or Problem(s) studied

Pneumococcal infection
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: [1] To demonstrate that 13vPnC is as immunogenic as 23vPS for the 12 common serotypes contained in 13vPnC as measured by serotype-specific opsonophagocytic assay (OPA) titers 1 month after initial study vaccination (year 0).
[2] To show that the proportion of subjects receiving 13vPnC and exhibiting a 4-fold rise in the 6A OPA titer is statistically significantly greater than the proportion of subjects receiving 23vPS exhibiting the same 4-fold rise, measured 1 month after initial study vaccination (year 0).

Secondary Objective: To show that:
[1] 13vPnC is more immunogenic than 23vPS for at least some of the 12 common serotypes
[2] anti-6A OPA titer in 13vPnC recipients > that in 23vPS recipients measured 1 month after initial vaccination
[3] immune response to a second dose of 13vPnC administered 1 year after an initial dose of 13vPnC is noninferior to immune response to the initial dose of 13vPnC; measured by serotype-specific OPA titers obtained 1 month after vaccination
[4] immune response to a second dose of 13vPnC administered 1 year after an initial dose of 13vPnC is noninferior to immune response to 23vPS (year 0) for the 12 common serotypes contained in the 13vPnC; measured by serotype-specific OPA titers obtained 1 month after vaccination
[5] anti-6A titer in recipients of a second dose of 13vPnC administered 1 year after the initial dose of 13vPnC is significantly greater than anti-6A titer in recipients of an initial dose of 23vPS (year 0), measured 1 month after vaccination

Primary end point(s): The primary immunologic comparisons are the pneumococcal responses to the 13 serotypes in subjects receiving 13vPnC relative to the pneumococcal responses in subjects receiving 23vPS. The primary endpoints for the 12 common serotypes are the serotype-specific OPA titers. For serotype 6A, the primary endpoint is the proportion of subjects exhibiting a 4-fold rise in anti-6A OPA titer.

Secondary ID(s)

6115A1-3005