A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine at Least 3 Years Before Study Enrollment

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002683-10-DE
• Date of registration: 13/06/2008
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.
• Public title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine at Least 3 Years Before Study Enrollment
• Scientific title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine at Least 3 Years Before Study Enrollment
• Date of first enrolment: 18/08/2008
• Target sample size: 1053
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002683-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Each subject must participate in the informed consent process and sign and date the informed consent form (ICF) before any procedures specified in this protocol are performed.
Subjects must meet the following criteria:
[1] Male or female adults 68 years of age and older at time of enrollment.
[2] Documented vaccination with 1 or more doses of 23vPS at least 3 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 therapy or hospitalization for worsening disease 6 weeks before receipt of study vaccine, 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 (up to 6 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 any vaccine within 28 days before study vaccination, except influenza vaccine. (See criteria for temporary delay of vaccination.)
[3] Vaccination with a diphtheria-containing vaccine within 6 months before test article administration or anticipated receipt before study completion.
[4] Documented S pneumoniae infection within the past 5 years.
[5] Residence in a nursing home, long-term care facility or other institution, or requirement of semi-skilled nursing care. An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
[6] Evidence of dementia or other severe cognitive impairment based on a Mini-Mental State Examination (MMSE) score of less than or equal to 21.
[7] 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 28 days before test article administration.
[8] Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease 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.
[9] Poor eyesight or missing eyesight, requiring third-party support to read.
[10] Receipt of any blood products, including immunoglobulin, within 6 months before test article administration, or anticipated receipt before study completion.
[11] In the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm due to insufficient muscle mass or limitation of arm movement that would interfere with the evaluation of the study objectives.
[12] Current anticoagulant therapy or a history of bleeding diathesis that would contraindicate intramuscular (IM) injection. (Note: antiplatelet drugs such as aspirin and clopidogrel are permitted).
[13] Intent to receive any other investigational vaccine or agent from 1 month (28 days) before study enrollment until the conclusion of the study.
[14] Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.


Criteria for Temporary Delay of Vaccination

The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition(s) has/have resolved and no other exclusion criteria are met:
1. Current febrile illness (oral temperature =38.0°C [100.4°F]) or other acute illness within 48 hours before test article administration.
2. Receipt of antibiotic therapy for an acute illness within 72 hours before test article administration.
3. Receipt of any inactivated vaccine within 14 days and any live vaccine within 28 days before test article administration.



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: To evaluate the acceptability of the safety profile of a single injection of 13vPnC administered at least 3 years after 1 or more nonstudy doses of 23vPS as measured by the incidence rates of local reactions, systemic events, and adverse events.

Secondary Objective:

Primary end point(s): The proportion of subjects reporting local reactions and systemic events on any day within the 14-day period after vaccination.

Secondary ID(s)

2007-002683-10-SE

6115A1-3000