Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Administered To Infants In Korea
- Conditions
- Pneumococcal diseaseMedDRA version: 17.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2008-004769-24-Outside-EU/EEA
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 180
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.
5.Previous vaccination with hepatitis B virus vaccine (HBV) at birth and approximately 1 month of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
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
1.Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines.
2.A previous anaphylactic reaction to any vaccine or vaccine-related component.
3.Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio or Hib vaccines.
4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5.Known or suspected immune deficiency or suppression.
6.History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7.Major known congenital malformation or serious chronic disorders.
8.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.
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; example, Synagis).
10.Participation in another investigational trial. Participation in purely observational studies is acceptable.
11.Infant who is a direct descendant (eg, child, grandchild) of the study site personnel.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the pneumococcal immune responses induced by 13vPnC relative to the pneumococcal immune responses induced by 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series.<br>To evaluate the acceptability of the safety profile of 13vPnC as measured by the <br>incidence rates of local reactions, systemic events, and adverse events (AEs).<br>;Secondary Objective: To evaluate the pneumococcal immune responses induced by 13vPnC relative to the pneumococcal immune responses induced by 7vPnC when measured 1 month after the toodler dose.<br>;Primary end point(s): Percentage of Subjects Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (=) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series;Timepoint(s) of evaluation of this end point: 1 month after the infant series (7 months of age)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Percentage of Subjects Achieving a Serotype-specific IgG Antibody Level =0.35 Mcg/mL Measured 1 Month After the Toddler Dose ;Timepoint(s) of evaluation of this end point: 1 month after the toddler dose (13 months of age)