Pneumococcal Disease, PD
Conditions
Interventions
Trial group:Trial vaccination
Control group:Control vaccination
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
No minimum to 5 Years
Inclusion criteria
Inclusion criteria: 1. Permanent healthy people aged 2~5 years, 12~23 months, 7~11 months or 2 months; 2. Obtain the consent of the volunteer's legal guardian and sign the informed consent form; 3. The legal guardian of the volunteer can comply with the requirements of the clinical trial protocol; 4. Armpit body temperature <=37.0°C.
Exclusion criteria
Exclusion criteria: 1. Those with a history of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccination; 2. Have a history of allergies and asthma, including a history of allergy to vaccines or vaccine ingredients, or have had serious adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioedema or abdominal pain, etc.; 3. Premature infants (delivered before the 37th week of pregnancy), low birth weight infants (weight at birth =38.0°C) in the past 3 days; 15. Is participating in other drug clinical trials or plans to participate in other drug clinical trials during the trial period; 16. Subject has any other factors that are not suitable for participation in the clinical trial, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rate of IgG antibodies against various types of pneumococcal bacteria 30 days after basic immunization;Geometric mean concentration (GMC) of IgG antibodies against various types of pneumococcal bacteria 30 days after basic immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Positive rates of IgG antibodies against various types of pneumococcal bacteria 30 days after booster immunization;Geometric mean concentration (GMC) of IgG antibodies against various types of pneumococcal bacteria 30 days after booster immunization; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed