Immunogenicity and safety study of GlaxoSmithKline Biologicals' Havrix administered on a 0, 6-month schedule concomitantly with GlaxoSmithKline Biologicals' Infanrix and Aventis Pasteur's Ac-tHIB in healthy children 15 months of age

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Active immunization against hepatitis A, , diphtheria, tetanus, pertussis and Haemophilus influenza type B infections of healthy children 15 months of age at the time of the first study vaccination.

• Registration Number: EUCTR2015-001530-25-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-25
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

Only subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol should be enrolled in the study,
A male or female child 12 or 13 months of age [i.e., subjects who have achieved their 12-month birthday but not yet achieved their 14-month birthday] at the time of entry into the Enrollment Phase,
Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix or Pediarix® and the three doses of Hib vaccine must have been administered as ActHIB, HibTITER®, OmniHIB®
Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix or Pediarix,
Written informed consent obtained from the parents or guardian of the subject,
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
Parents/guardian of the subject must have a telephone or be able to be contacted by telephone.

Are the trial subjects under 18? yes
Number of subjects for this age range: 468
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccin(s within 31 days preceding the first dose of study vaccine, or planned use during the study period,
Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.
Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccines should be administered before or during the Enrollment Phase of the study but >= 42 days prior to administration of study vaccines at Day 0.
In order to comply with the ACIP-recommended admini-stration of Hib vaccine during the age range of 12-15 months, subjects in the HAV Group ONLY should receive their fourth dose of the Hib vaccine as commercially-available ActHIB during the interval between Visit 3 of the Active Phase and the subject's 19-month birthday.
Previous vaccination against DTaP using a commercially-available brand other than Infanrix or Pediarix or against Hib using a commercially-available brand other than ActHIB, HibTITER or OmniHIB.
Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
Previous vaccination against hepatitis A,
History of hepatitis A,
Known exposure to hepatitis A,
History of diphtheria, tetanus, pertussis and/or Haemo-philus influenza type b,
Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza
type b within 31 days prior to the start of the study,
History of non-response to any vaccine in the current routine immunization schedule,
Any confirmed or suspected immunosuppressive or im-munodeficient condition, including human immunodefi-ciency virus infection,
A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix, Infanrix or ActHIB including 2-phenoxyethanol, neomycin and gelatin,
History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the Havrix and Infanrix needleless pre-filled syringes and the stopper of the ActHIB diluent vial contain dry natural latex rubber.
Major congenital defects or serious chronic illness,
History of any neurologic disorder.,
Acute disease at the time of vaccination.
Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrollment Phase, the Active Phase and the Extended Safety Follow-up Phase.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified