Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Keywords
vaccine
Brief summary
There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female adults 65 years of age and older. * Determined by medical history, physical examination, and clinical judgment to be eligible for the study. * Expected to be available for the duration of the trial (up to approximately 13 months).
Exclusion criteria
* Received previous immunization with 23vPS. * Serious chronic disorders including metastatic malignancy * Known or suspected hypersensitivity to any vaccine or vaccine components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG). | — |
| Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC. | — |
Outcome results
None listed