Healthly infants Level: HLT Classification code 10004047
Conditions
Interventions
Product Name: 13-valent Pneumococcal Conjugate vaccine
Pharmaceutical Form: Suspension for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30.8-
Product
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3 months 75 to 105 days at time of enrollment. 2. Available for entire study period and whose parents/legal guardian can be reached by telephone. 3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight all subjects must meet inclusion criterion number 3. 5. Parent/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 61650; . 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: Primary objective To demonstrate that the immune response induced by Infanrix hexa given with 13vPnC is noninferior to the immune response induced by Infanrix hexa given with 7vPnC when measured 1 month after the toddler dose. Response to the following antigen in Infanrix hexa will be assessed hepatitis B. 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 response to 13vPnC 1 month after the infant series as measured by serum immunoglobulin G IgG responses. To assess the immune response to 13vPnC before and 1 month after the toddler dose as measured by serum IgG responses.;Secondary Objective: 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 infant series and 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 infant series. To assess the immune response induced by Infanrix hexa given with 13vPnC relative to the immune response induced by Infanrix hexa given with 7vPnC at an alternative cutoff level when measured 1 month after the infant series and 1 month after the toddler dose;Primary end point(s): See primary objectives | — |
Countries
Italy
Outcome results
None listed