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)

NCT02736240 | Completed Phase 3

• 1 other identifier: 022152015003
• Study Type: interventional
• Target: 2,760
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Diseases Caused by Streptococcus Pneumoniae Serotypes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

7-valent pneumococcal conjugate vaccine

Biological: 7-valent pneumococcal conjugate vaccine

Test Arm

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal polysaccharide conjugate vaccine

Interventions

7-valent pneumococcal conjugate vaccine BIOLOGICAL

Control Arm

13-valent pneumococcal polysaccharide conjugate vaccine BIOLOGICAL

Test Arm

Eligibility Criteria

• Age: 2 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Walvax Biotechnology Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 27798013 DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Nianmin Shi

  Beijing Chaoyang disease control and prevention center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 13, 2016
• Study Start: April 8, 2016
• Primary Completion: December 3, 2017
• Study Completion: December 3, 2017
• Last Updated: October 14, 2020

Record last verified: 2020-10