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NCT Number: NCT00534885

Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).

Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

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Key information

Conditions

Hepatitis A Digestive System Diseases Enterovirus Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

12 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changzhou City Center for Disease Control and Prevention

Changzhou, Jiangsu, 213003, China

About this study

The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.

Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.

After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Health children from 1 to 10 years
  • Not participate in any other trial during the course of the trial
  • Informed consent

Exclusion criteria

  • Any history of allergic reactions or convulsions following vaccination
  • Other known or planned vaccination within 1 month prior to the study and during the study period
  • Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
  • Presence of any congenital abnormality, upgrowth obstacle
  • Any history/suspicion/presence of neurology and Lunacy
  • Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
  • Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
  • Abnormal ALT
  • Positive markers for anti-HAV and HBV（HBsAg）infection
  • Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.

Treatment and study plan

Healive® Lot 1

Biological

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

Healive® Lot 2

Biological

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

Healive® Lot 3

Biological

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

Havrix

Biological

Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart

Primary outcomes

  1. Anti-HAV titer

    Time frame: 7 months after the first dose

    To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.

Secondary outcomes

  1. Solicited adverse reactions (AE): local reactions and systematic reactions

    Time frame: 72 hours after each injection

    Solicited AEs were recorded until 72 hours after each injection

  2. Unsolicited adverse reactions (AE)

    Time frame: 7 months after the first dose

    Unsolicited AEs were recorded until month 7

  3. Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate

    Time frame: baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose

    Blood samples were collected at day 0, month 1, 6, 7, 18, 30, 42, 54, 66,112, 138 after the first dose to assess the change of long-term immune response. Anti-HAV antibodies were assessed by microparticle enzyme immunoassay (MEIA) assay (cut off: 20 mIU/ml)

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2007
Registry last updated
Sep 4, 2019

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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