None listed
Conditions
Interventions
Group 1 Type of group
Liquid Pedvax HIB 0.5 mcg at 6, 10, and 14 weeks
Group 7 Type of group
ActHIB® at 6, 10, and 14 weeks
booster at 36 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy infants approximately six weeks of age (+/- 1 week).
Exclusion criteria
Exclusion criteria: - Hypersensitivity to any of the components of the vaccines. - Known or suspected impairment of immunologic function. - Recent (101°F or 38.3°C, oral equivalent) or underlying medical problems. - Previous vaccination with any other Hib conjugate or polysaccharide vaccine. - Vaccination with other vaccines except those specified in the protocol, or the receipt of immune globulin prior to, or during the trial. Vaccination with BCG and OPV at birth is allowable; rescue doses of BCG for non-responders to the birth dose are also allowable. - Recent household, daycare, or school exposure (<14 days) to invasive Hib disease. - Past history of invasive Hib disease. - Any medical condition, which in the opinion of the investigator, may interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of subjects with anti-PRP titters of >1.0 mcg/mL in at least one of the three lower dose groups eliciting a response similar to the 7.5-mcg control group. Measure:Primary immunogenicity criteria Timepoints:One month Postinjection 3 for the 3.0, 1.0, and 0.5mcg groups, and at 1 month Postinjection 2 for the 7.5mcg group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of subjects with anti-PRP titters of >1.0 mcg/mL in at least one of the three lower dose groups eliciting a response similar to the 7.5-mcg control group. Measure:Secondary immunogenicity criteria Timepoints:One month Postinjection 3. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed