Last updated: 12/23/2020 02:30:06
This study will evaluate the persistence of hepatitis A antibodies, 8 years and 10 years later, in children who had received Havrix at selected health centres of Panama
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Long term hepatitis A virus (HAV) antibody persistence in children vaccinated with 1 dose and those vaccinated with 2 doses of Havrix in Panama
Trial description: The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with anti-hepatitis A virus (HAV) seropositivity status at approximately 8 years following last administered Havrix dose
Timeframe: At approximately 8 years after the last administered vaccine dose
Number of subjects with anti-HAV seropositivity status at approximately 10 years following last administered Havrix dose
Timeframe: At approximately 10 years after the last administered vaccine dose
Secondary outcomes:
Anti-HAV antibody concentrations at approximately 8 years following last administered Havrix dose
Timeframe: At approximately 8 years after the last administered vaccine dose
Anti-HAV antibody concentrations at approximately 10 years following last administered Havrix dose
Timeframe: At approximately 10 years after the last administered vaccine dose
Number of subjects with anti-HAV antibody concentration ≥ 15 mIU/mL at approximately 8 years following last administered Havrix dose - exploration of non-inferiority of the 1-dose schedule compared to the 2-dose schedule of Havrix
Timeframe: At approximately 8 years after the last administered vaccine dose
Number of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL at approximately 10 years following last administered Havrix dose - exploration of non-inferiority of the 1-dose schedule compared to the 2-dose schedule of Havrix
Timeframe: At approximately 10 years after the last administered vaccine dose
Interventions:
Enrollment:
1201
Primary completion date:
2018-22-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Patricia Juliao, Ivonne Abadia, Sarah Welby, Stephanie Wery, Digna Wong, Tirza De Leon, Rodrigo Deantonio, Laura Naranjo, Adrienne Guignard, and Cinzia Marano. Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama. Vaccine. 2021 Jan 3;39(1):26-34.doi: 10.1016/j.vaccine.2020.11.030.
Medical condition
Hepatitis A Vaccine
Product
SB208109
Collaborators
Not applicable
Study date(s)
June 2016 to August 2018
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
8 - 15 years
Accepts healthy volunteers
Yes
- Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed assent/consent obtained from the subject or subject’s parent(s)/ LAR(s) of the subject.
- Child in care.
- Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed assent/consent obtained from the subject or subject’s parent(s)/ LAR(s) of the subject.
- Available HAV vaccination records.
- Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
- Children with ≥ 7 years and < 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and < 13 years between last dose and Persistence Visit 1’ (Year 10).
Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion criteria:
- Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
- Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).
Child in care.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-22-08
Actual study completion date
2018-22-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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