Pneumococcal Infections
Conditions
Keywords
Vaccine, Healthy Infants
Brief summary
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
Interventions
BIOLOGICALPrevenar
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 100 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female children 2 months of age (42 to 100 days) in good health. * An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study. * Infants whose parent(s)/guardian(s) will be available for the entire study period.
Exclusion criteria
* Hypersensitivity to any component of the vaccine, including diphtheria toxoid * Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy. Other exclusions apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age | — |
Outcome results
None listed