None listed
Conditions
Interventions
Intervention1: 13-valent pneumococcal conjugate vaccine: 1 dose at 6, 10, 14 weeks and 12 months of age
Control Intervention1: 7-valent pneumococcal conjugate vaccine: 1 dose at 6, 10, 14 weeks and 12
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: Aged 6 weeks (42 to 72 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. Weight of 3.5 kg or greater at the time of enrollment.
Exclusion criteria
Exclusion criteria: Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, or H influenzae type b (Hib) conjugate vaccines. A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with pneumococcal conjugate, Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or measles 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 disorder. 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, grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pneumococcal immune responses induced by 13vPnC relative to the pneumococcal immune responses induced by 7vPnC, when measured 1 month after the infant series. Timepoint: 1 month after infant series. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the pneumococcal immune responses induced by 13vPnC relative to the pneumococcal immune responses induced by 7vPnC when measured 1 month after the toddler dose.Timepoint: 1 month after the toddler dose. | — |
Countries
India
Contacts
Public ContactSwapnali Raut
Representing Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.)
Outcome results
None listed