Healthy infants
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 2 months (56 to 112 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 or legal guardian must be able to complete all relevant study procedures during subject 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, or hepatitis B vaccines. 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, or pneumococcal 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 or H influenzae type b. 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 disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. 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 trial. 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 |
|---|---|
| Main Objective: - To demonstrate that the immune responses to the 7 common pneumococcal conjugates induced by 13vPnC are noninferior to the immune responses induced by 7vPnC when measured 1 month after the infant series. - To demonstrate that the immune responses to the 6 additional pneumococcal conjugates induced by 13vPnC are noninferior to the lowest immune response, among the 7 common pneumococcal conjugates, induced by 7vPnC when measured 1 month after the 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 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).;Primary end point(s): See primary objectives;Secondary Objective: - To assess the pneumococcal immune response induced by 13vPnC relative to the immune response induced by 7vPnC when measured 1 month after the toddler 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 when measured 1 month after the toddler dose. Responses to the following antigens in Infanrix hexa will be assessed: hepatitis B, Hib, and diphtheria.· - 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 infant series and 1 month after the toddler dose. Responses to the following antigens in Infanrix hexa will be assessed: diphtheria and Hib. | — |
Countries
Germany
Outcome results
None listed