Please select the outcome measures that correspond to the clinical trial below.
Title: Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Brief Summary: The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.


Options:
A: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
B: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).)
C: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months))
D: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine); Antibody Concentration Against Protein D (PD) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine)

Answer: B