Pneumococcal disease caused by Streptococcus pneumoniae
Conditions
Interventions
Non- OPA subgroup (Blood was collected from 2.0 mL to 2.5 mL and only 13 serotype-specific pneumococcal IgG antibody geometric mean concentration (GMC) values and IgG antibody concentrations were dete
OPA Subgroup (Blood was collected from 4.0mL to 4.5mL, and 13 serotype-specific pneumococcal IgG antibody geometric mean concentration values (GMC), IgG antibody concentration and OPA geometric mean t
Sponsors
Hebei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Children who had been enrolled in the phase III clinical trial of 13-valent pneumococcal polysaccharide conjugate vaccine at the age of 2 months (minimum of 6 weeks), 3 months, and 7 months to 71 months, and had completed the full course of immunization according to the corresponding age immunization procedures. (2) Volunteers and their legal guardians voluntarily agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Volunteer has received any pneumococcal-based vaccine to date after enrollment in the Phase III clinical trial of 13-valent pneumococcal polysaccharide conjugate vaccine. (2) Volunteer has a past/present history of culture-confirmed invasive disease caused by Streptococcus pneumoniae. (3) Volunteer is known or suspected to have immunologic deficiencies (e.g., Guillain-Barre syndrome, etc.), including ongoing immunosuppressive therapy (e.g., radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic medications, etc.), and HIV infection to the present after enrollment in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine. (4) An interval of <= 90 days from the most recent receipt of blood products including immunoglobulins. (5) Any condition that, in the opinion of the investigator, has the potential to affect the assessment of study immunogenicity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration values (GMC) of IgG antibodies specific to pneumococcus of 13 serotypes and proportion of participants with IgG antibody concentrations >=0.35 µg /mL (positivity rate) for all participants in each age group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with 13 serotype-specific pneumococcal IgG antibody concentrations IgG >= 1.0 µg/mL in each age group;Proportion of participants with geometric mean titers (GMT) of 13 serotypes of anti-pneumococcal OPA in vaccines and OPA titers >=1:8 in the OPA subgroups of participants in each age group; | — |
Countries
China
Contacts
Public ContactLulu Pan
Hebei Provincial Center for Disease Control and Prevention
Outcome results
None listed