Infections, Streptococcal
Conditions
Keywords
Streptococcus pneumonia, vaccine
Brief summary
Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.
Interventions
BIOLOGICALPneumococcal (vaccine)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 16 Weeks
Healthy volunteers
Yes
Inclusion criteria
* male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.
Exclusion criteria
* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. * Previous vaccinations against diseases which are targeted by the vaccines used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post at least 1 dose: rectal fever >39°C | — |
Secondary
| Measure | Time frame |
|---|---|
| Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens | — |
Countries
Germany, Poland, Spain
Outcome results
None listed