Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in 2-71 Months Old Healthy Infants and Toddlers (the Youngest Could be 6 Weeks Old)

Phase 3

Completed

• Conditions: Diseases Caused by Streptococcus Pneumoniae Serotypes
• Interventions: Biological: 7-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal polysaccharide conjugate vaccine

• Registration Number: NCT02736240
• Lead Sponsor: Walvax Biotechnology Co., Ltd.

Brief Summary

The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-07
• Study Start: 2016-04-08
• Study First Posted: 2016-04-13
• Primary Completion: 2017-12-03
• Study Completion: 2017-12-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-11
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2760

Inclusion Criteria

• 2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator;
• The statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form;
• The subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol;
• Never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days);
• The auxillary temperature ≤37℃.

Exclusion Criteria

• Has already been immunized with pneumococcus vaccine no matter it is experimental or marketed;
• With the history of invasive disease caused by streptococcus pneumonia by culture;
• With the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product;
• Infant that the birth weight is lighter than 2.5 kg;
• With the history or the family history of seizure, epilepsy, cerebropathy and psychosis ;
• Infant with the abnormal labor (difficult labor, deliver with apparatus) or with the history of asphyxia or nervous damage;
• With the history of thrombocytopenia or other coagulation disorders by definite diagnosis;
• Infant or toddler with pathological jaundice by diagnosis;
• Be known with or suspected with immunological dysfunction, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), HIV infection etc. ;
• Be known with serious congenital malformation or serious chronic disease; suffer from congenital malformation or be diagnosed with serious chronic disease (eg. Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome);
• Be known with or suspected with diseases including: disease of respiratory system, acute infection or the active period of chronic disease, serious cardiovascular disease, hepatic-nephrotic disease, malignant tumor, skin disease;
• Has taken blood product or globulin (the hepatitis B immune globulin is allowed);
• Be participating in other clinical trials;
• Any other situation which is considered to influence the evaluation of the study by investigators .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	7-valent pneumococcal conjugate vaccine	7-valent pneumococcal conjugate vaccine
Test Arm	13-valent pneumococcal polysaccharide conjugate vaccine	13-valent pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
positive rate after booster dose	30 days after booster dose	the rate of the immunoglobulin G ≥0.35μg/ml after booster dose
GMC after booster dose	30 days after booster dose	geometrical mean concentration of immunoglobulin G after booster dose
positive rate after infant doses	30 days after infant doses	the rate of the immunoglobulin G ≥0.35μg/ml after infant doses
GMC after infant doses	30 days after infant doses	geometrical mean concentration of immunoglobulin G after infant doses