N/A
N=600
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
Hepatitis A Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT02712359 ↗Enrolled (actual)
600
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose — 223; 293; 77; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sample collection (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose |
223; 293; 77; 7 | — |
| PRIMARY Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose |
215; 289; 84; 11 | — |
| SECONDARY Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose |
40.2; 123.9 | — |
| SECONDARY Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose |
26.0; 82.1 | — |
| SECONDARY 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 |
223; 293 | <0.0001 sig |
| SECONDARY 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 |
215; 289 | <0.0001 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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.
- 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).
Exclusion Criteria
- Child in care.
- 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).
Data sourced from ClinicalTrials.gov (NCT02712359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.