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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

Information source: Crucell Holland BV
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis A

Intervention: Epaxal (Biological); Havrix 720 (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Crucell Holland BV

Official(s) and/or principal investigator(s):
Ron Dagan, MD, Principal Investigator, Affiliation: Soraka Medical Center
Shai Ashkenazi, MD, Principal Investigator, Affiliation: Schneider Children's Medical Center, Israel

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).

Clinical Details

Official title: A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (EpaxalŽ) 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Anti-hepatitis A virus (HAV) antibody concentrations

Anti-hepatitis A virus (HAV) antibody concentrations

Secondary outcome:

Geometric mean concentrations (GMC)

Proportion of seroprotected subjects

Eligibility

Minimum age: 12 Months. Maximum age: 15 Months. Gender(s): Both.

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

Locations and Contacts

Pediatric Infectious Diseases Unit, Soraka Medical Center, Beer Sheva 84101, Israel

Schneider Children's Medical Center of Israel, Petah Tiqva 49202, Israel

Additional Information

Starting date: March 2011
Last updated: July 28, 2014

Page last updated: August 23, 2015

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