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Completed

NCT Number: NCT02601040

Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.

Completed

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Key information

Age range

18 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Only subjects fulfilling all of the following criteria will be eligible for the study:
  • People aged from 18 months to 65 years old.
  • The subjects or subjects' guardians are able to understand and sign the informed consent
  • The subjects or subjects' guardians allow to comply with the requirements of the protocol
  • Subjects with temperature <=37.0°C on axillary setting
  • The subjects have signed informed consent already

Exclusion criteria

  • Subjects will not be eligible for the study if any of the following criteria is met:
  • Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
  • Have a history of neurological symptoms or signs
  • Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
  • Suffering from serious chronic diseases
  • Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
  • Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
  • Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
  • Any prior diseases including human immunodeficiency virus infection or related
  • Bleeding constitution or prolong bleeding time situation
  • Accept hepatitis A vaccination within a month
  • Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
  • People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
  • Caught a fever with axillary temperature 38°C or higher in past 3 days
  • Take part in another clinical researchers
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  • Pregnancy test result is positive

Treatment and study plan

Attenuated Hepatitis A Vaccine, H2 Strain

Biological

6.50 lgCCID50/ml in babies aged 18-35 months\\6.50 lgCCID50/ml in children aged 3-16 years \\6.50 lgCCID50/ml in adults aged 17 up to 65 years old

Inactivated Hepatitis A Vaccine, Lu8 Strain

Biological

320EU/Vial in babies aged 18-35 months \\320EU/Vial in children aged 3-16 years \\640EU/Vial in adults aged 17 up to 65 years old\\boost at month 6\\two-dose

Group A Meningococcal Polysaccharide vaccine

Biological

30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Primary outcomes

  1. Changes of hepatitis A antibody concentration

    Time frame: 37 months

    Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 28 days

    Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

Registry information

Official study title

Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Nov 10, 2015
Registry last updated
Nov 10, 2015

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.

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