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)

Last updated: October 11, 2020
Sponsor: Walvax Biotechnology Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT02736240
022152015003
  • Ages 2-71
  • All Genders
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 2-71 months (the youngest could be 6 weeks old) infants or toddlers which arepositively healthy based on the medical history, the physical examination and thejudgment of the investigator;

  • The statutory guardian (or the consignor) of the subject agree his/her childparticipate 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 withthe requests of the clinical study protocol;

  • Never be immunized with any pneumococcus vaccine, and didn't get immunization with anyother preventive product in the past 10 days (didn't get immunized with attenuatedlive vaccine in the past 14 days);

  • The auxillary temperature ≤37℃.

Exclusion

Exclusion Criteria:

  • Has already been immunized with pneumococcus vaccine no matter it is experimental ormarketed;

  • 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 andpsychosis ;

  • Infant with the abnormal labor (difficult labor, deliver with apparatus) or with thehistory of asphyxia or nervous damage;

  • With the history of thrombocytopenia or other coagulation disorders by definitediagnosis;

  • Infant or toddler with pathological jaundice by diagnosis;

  • Be known with or suspected with immunological dysfunction, including immunosuppressivetherapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites,cytotoxic drug), HIV infection etc. ;

  • Be known with serious congenital malformation or serious chronic disease; suffer fromcongenital malformation or be diagnosed with serious chronic disease (eg. Downsyndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barresyndrome);

  • Be known with or suspected with diseases including: disease of respiratory system,acute infection or the active period of chronic disease, serious cardiovasculardisease, 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 byinvestigators .

Study Design

Total Participants: 2760
Study Start date:
April 08, 2016
Estimated Completion Date:
December 03, 2017