Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines
A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal®) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.
2 other identifiers
interventional
327
1 country
2
Brief Summary
The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2007
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2013
CompletedApril 8, 2019
March 1, 2019
6.3 years
February 28, 2011
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
5.5 years
Anti-hepatitis A virus (HAV) antibody concentrations
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
7.5 years
Secondary Outcomes (2)
Geometric mean concentrations (GMC)
5.5 and 7.5 years
Proportion of seroprotected subjects
5.5 and 7.5 years
Study Arms (3)
Group A
EXPERIMENTALEpaxal + concomitant administration of DTPaHibIPV, MMR, OPV
Group B
EXPERIMENTALEpaxal, with administration of DTPaHibIPV, MMR, OPV one month later
Group C
ACTIVE COMPARATORHavrix 720 + concomitant administration of DTPaHibIPV, MMR
Interventions
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
Eligibility Criteria
You may qualify if:
- Original study:
- Written informed consent obtained from the parent/legal guardian of the subject.
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study.
- At least 8 kg of body weight at age of 12 months.
- Follow-up phase:
- Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.
You may not qualify if:
- Original study:
- Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy
- Children having received a documented dose of MMR during infancy
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of systemic corticosteroids (inhaled and topical steroids are allowed).
- Administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
- Previous vaccination against hepatitis A.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness
- Acute disease at the time of enrolment.
- Follow-up phase:
- Children who had received a hepatitis A antigen containing vaccine since the last visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Beersheba, Israel
Unknown Facility
Petah Tikva, Israel
Related Publications (1)
Dagan R, Ashkenazi S, Livni G, Go O, Bagchi P, Sarnecki M. Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal Hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age. Pediatr Infect Dis J. 2016 Jul;35(7):e220-8. doi: 10.1097/INF.0000000000001176.
PMID: 27093164RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Dagan, MD
Soraka Medical Center
- PRINCIPAL INVESTIGATOR
Shai Ashkenazi, MD
Schneider Children's Medical Center, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 3, 2011
Study Start
March 14, 2007
Primary Completion
July 8, 2013
Study Completion
July 8, 2013
Last Updated
April 8, 2019
Record last verified: 2019-03