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Completed

NCT Number: NCT00603252

Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

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Key information

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Wilrijk, Belgium

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About this study

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female who completed the primary vaccination phase of the study.
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.

Treatment and study plan

Twinrix

Biological

Engerix-B

Biological

Havrix

Biological

HBVAXPRO

Biological

Vaqta

Biological

Primary outcomes

  1. Anti-HAV immune response to the challenge dose

  2. Anti-HBs antibody response to the challenge dose

Secondary outcomes

  1. Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects

    Time frame: Two weeks and one month after the challenge dose

  2. Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects

    Time frame: Two weeks and one month after the challenge dose

  3. Occurrence and intensity of solicited local symptoms

    Time frame: In the 4-day follow-up period after the challenge dose

  4. Occurrence, intensity and relationship of solicited general symptoms

    Time frame: In the 4-day follow-up period after the challenge dose

  5. Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported

    Time frame: During the 31-day follow-up period after the challenge dose

  6. Occurrence of all serious adverse events (SAEs) reported

    Time frame: Following the administration of the challenge dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2008
Registry last updated
Mar 14, 2017

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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