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Completed

NCT Number: NCT02736240

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)

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)

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Key information

Age range

2 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

7-valent pneumococcal conjugate vaccine

Biological

13-valent pneumococcal polysaccharide conjugate vaccine

Biological

Primary outcomes

  1. positive rate after infant doses

    Time frame: 30 days after infant doses

    the rate of the immunoglobulin G ≥0.35μg/ml after infant doses

  2. GMC after infant doses

    Time frame: 30 days after infant doses

    geometrical mean concentration of immunoglobulin G after infant doses

  3. positive rate after booster dose

    Time frame: 30 days after booster dose

    the rate of the immunoglobulin G ≥0.35μg/ml after booster dose

  4. GMC after booster dose

    Time frame: 30 days after booster dose

    geometrical mean concentration of immunoglobulin G after booster dose

Sponsors and collaborators

Lead sponsor

Walvax Biotechnology Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2016
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.