Healthy infants - Niños sanos
Conditions
Interventions
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 1
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration numb
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 2 months (42 to 98 days) at time of enrollment. 2. Available for entire study period and whose parent/legal guardian can be reached by telephone. 3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 4. 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: 1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, MMR, or meningococcal vaccine. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, MMR, pneumococcal, or meningococcal vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b (Hib). 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis). 11. Participation in another investigational study. Participation in purely observational studies is acceptable. 12. Infant who is a direct descendant (child, grandchild) of the study site personnel. 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy. 10. Receipt of blood products or gamma-globulin (including Hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagisâ). 11. Participation in another investigational study. Participation in purely observational studies is acceptable. 12. Infant who is a direct descendant (child, grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): See primary objectives;Main Objective: Primary objectives· - To demonstrate that the immune response induced by Meningitec given with 13vPnC is noninferior to the immune response induced by Meningitec given with 7vPnC when measured 1 month after the 2-dose Meningitec infant series. - To demonstrate that the immune responses induced by Infanrix hexa given with 13vPnC are noninferior to the immune responses induced by Infanrix hexa given with 7vPnC when measured 1 month after the 3-dose infant series. Safety objective·- To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local injection site reactions, systemic events, and adverse events (AEs). 13vPnC Immunogenicity objectives·- To assess the immune responses to 13vPnC 1 month after the second dose and 1 month after the third dose of a 3-dose infant series as measured by serum immunoglobulin G (IgG) responses. - To assess the immune responses to 13vPnC 1 month after the toddler dose as measured by serum IgG responses.;Secondary Objective: - To assess the immune response induced by Meningitec given with 13vPnC relative to the immune response induced by Meningitec given with 7vPnC when measured 1 month after the toddler dose. - To assess the immune responses induced by Infanrix-IPV+Hib given with 13vPnC relative to the immune responses induced by Infanrix-IPV+Hib given with 7vPnC when measured 1 month after the toddler dose. - To assess the immune response induced by Infanrix hexa given with 13vPnC relative to the immune response induced by Infanrix hexa given with 7vPnC when measured 1 month after the second dose. - To assess the immune responses induced by Infanrix hexa given with 13vPnC relative to the immune responses induced by Infanrix hexa given with 7vPnC at alternative cutoff levels when measured 1 month after the 3-dose infant series and 1 month after the Infanrix-IPV+Hib toddler doseand measured 1 month after the second dose. | — |
Countries
Spain
Outcome results
None listed