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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)

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ClinicalTrials.gov Identifier: NCT02736240
Recruitment Status : Unknown
Verified April 2016 by Walvax Biotechnology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Diseases Caused by Streptococcus Pneumoniae Serotypes Biological: 7-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal polysaccharide conjugate vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Developed Cooperatively by YunNan Walvax Biotechnology Co., Lt and Yuxi Walvax Biotechnology Co., Lt Among 2-71 Months (the Youngest Could be 6 Weeks) Healthy Infants and Toddlers by Randomized Blind Method With Similar Control in Multi-centers.
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Arm
7-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Experimental: Test Arm
13-valent pneumococcal conjugate vaccine
Biological: 13-valent pneumococcal polysaccharide conjugate vaccine



Primary Outcome Measures :
  1. the rate of the immunoglobulin G ≥0.35μg/ml in the subjects with the full series of doses [ Time Frame: 30 days after finishing the infants doses and the toddlers doses (if necessary) ]
  2. the geometrical mean concentration(GMC) of the immunoglobulin G in the subjects with the full series of doses [ Time Frame: 30 days after finishing the infants doses and the toddlers doses (if necessary) ]
  3. the incidence of the local adverse reactions and the systematic adverse reactions [ Time Frame: 30 days after finishing the infants doses and the toddlers doses (if necessary) ]


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Ages Eligible for Study:   2 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736240


Contacts
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Contact: Shuyuan Yang, Master 8618687832269 ynwsysy@walvax.com

Sponsors and Collaborators
Walvax Biotechnology Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Walvax Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02736240     History of Changes
Other Study ID Numbers: 022152015003
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs