Clinical trial NCT01307436: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A
Keywords: Hepatitis A Vaccine
Combined Vaccines
DTP Vaccine
MMR Vaccine
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-03-03
Enrollment: 327
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Anti-hepatitis A virus (HAV) antibody concentrations
timeFrame: 5.5 years
measure: Anti-hepatitis A virus (HAV) antibody concentrations
timeFrame: 7.5 years
Secondary outcomes:
measure: Geometric mean concentrations (GMC)
timeFrame: 5.5 and 7.5 years
measure: Proportion of seroprotected subjects
timeFrame: 5.5 and 7.5 years
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
city: Petach-Tikva
country: Israel
Study officials:
affiliation: Soraka Medical Center
name: Ron Dagan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schneider Children's Medical Center, Israel
name: Shai Ashkenazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.