Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female aged 50 to 59 years
- Determined by medical history, physical examination and clinical judgement to be eligible for the study
- Able to complete electronic diary
- Available for the 5 year 9 month duration of the study
Exclusion criteria
- Previous vaccination with any licensed or experimental pneumococcal vaccine
- Allergic to egg proteins and chicken proteins
- History of Guillian-Barre syndrome
- Vaccination with TIV within 6 months before study start
- Vaccination with diphtheria-containing vaccine within 6 months of study start
- Serious chronic disorders including immunodeficiency or metastatic malignancy
- Known or suspected hypersensitivity to any vaccine or vaccine component
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,116 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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