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)

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.

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)

Study Overview

• Status: Completed
• Conditions: Diseases Caused by Streptococcus Pneumoniae Serotypes
• Intervention / Treatment: Biological: 7-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal polysaccharide conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 2760
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive rate after infant doses	the rate of the immunoglobulin G ≥0.35μg/ml after infant doses	30 days after infant doses
GMC after infant doses	geometrical mean concentration of immunoglobulin G after infant doses	30 days after infant doses
positive rate after booster dose	the rate of the immunoglobulin G ≥0.35μg/ml after booster dose	30 days after booster dose
GMC after booster dose	geometrical mean concentration of immunoglobulin G after booster dose	30 days after booster dose

Collaborators and Investigators

• Sponsor: Walvax Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Nianmin Shi, Beijing Chaoyang disease control and prevention center

Publications and helpful links

General Publications

• Chen JJ, Yuan L, Huang Z, Shi NM, Zhao YL, Xia SL, Li GH, Li RC, Li YP, Yang SY, Xia JL. Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China. BMJ Open. 2016 Oct 19;6(10):e012488. doi: 10.1136/bmjopen-2016-012488.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2016
• Primary Completion (Actual): December 3, 2017
• Study Completion (Actual): December 3, 2017

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 022152015003