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
This study is ongoing, but not recruiting participants.
Sponsor:
Crucell Holland BV
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01307436
First received: February 28, 2011
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis A |
Biological: Epaxal Biological: Havrix 720 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by Crucell Holland BV:
Primary Outcome Measures:
- Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 5.5 years ] [ Designated as safety issue: No ]Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
- Anti-hepatitis A virus (HAV) antibody concentrations [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
Secondary Outcome Measures:
- Geometric mean concentrations (GMC) [ Time Frame: 5.5 and 7.5 years ] [ Designated as safety issue: No ]GMCs of anti-HAV antibodies
- Proportion of seroprotected subjects [ Time Frame: 5.5 and 7.5 years ] [ Designated as safety issue: No ]Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV
|
Biological: Epaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
|
|
Experimental: Group B
Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later
|
Biological: Epaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
|
|
Active Comparator: Group C
Havrix 720 + concomitant administration of DTPaHibIPV, MMR
|
Biological: Havrix 720
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
|
Eligibility| Ages Eligible for Study: | 12 Months to 15 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307436
Locations
| Israel | |
| Pediatric Infectious Diseases Unit, Soraka Medical Center | |
| Beer Sheva, Israel, 84101 | |
| Schneider Children's Medical Center of Israel | |
| Petah Tiqva, Israel, 49202 | |
Sponsors and Collaborators
Crucell Holland BV
Investigators
| Principal Investigator: | Ron Dagan, MD | Soraka Medical Center |
| Principal Investigator: | Shai Ashkenazi, MD | Schneider Children's Medical Center, Israel |
More Information
No publications provided
| Responsible Party: | Crucell Holland BV |
| ClinicalTrials.gov Identifier: | NCT01307436 History of Changes |
| Other Study ID Numbers: | EPA 004 FU |
| Study First Received: | February 28, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Crucell Holland BV:
|
Hepatitis A Vaccine Combined Vaccines DTP Vaccine MMR Vaccine |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 21, 2013