Healthy infants
Conditions
Interventions
Product Name: 13vPnC pilot scale
Product Code: 6096A1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 1
Concentration unit: µg/ml microgram(s)/m
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged 2 months (42 to 98 days) at time of enrollment. • Available for entire study period and whose parent/legal guardian can be reached by telephone. • Healthy infant as determined by medical history, physical examination, and judgment of the investigator. • Parent/legal guardian must be able to complete all relevant study procedures during study participation. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous vaccination with licensed or investigational pneumococcal, Haemophilus influenzae type b (Hib) conjugate, diphtheria, tetanus, pertussis, or polio vaccines. • A previous anaphylactic reaction to any vaccine or vaccine-related component. • Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines. • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. • Known or suspected immune deficiency or suppression. • History of culture-proven invasive disease caused by S pneumoniae. • Major known congenital malformation or serious chronic disorders. • Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy. • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). • Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable. • Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: • To assess the pneumococcal immune responses induced by manufacturing scale 13vPnC relative to the immune responses induced by pilot scale 13vPnC when measured 1month after the infant series. ;Secondary Objective: Safety Objective: • To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).;Primary end point(s): The primary endpoint for each of the pneumococcal serotypes is the proportion of subjects achieving a serotype specific IgG antibody concentration = 0.35 µg/mL measured 1 month after the infant series. This choice of an endpoint is based upon a World Health Organization (WHO) guideline for the pneumococcal serotypes. | — |
Countries
Poland
Outcome results
None listed