A clinical trial to study the effects of a 13-valent pneumococcal conjugate vaccine in healthy infants given with routine vaccinations in India.
- Registration Number
- CTRI/2009/091/000548
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 708
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>Timepoint: 1 month after infant series.
- Secondary Outcome Measures
Name Time Method 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.