Evaluate a Vaccine against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

Phase 1

• Conditions: Healthy children between 12-22 months (including the day before the 23-month birthday) of age at the time of vaccination with no history of measles, mumps, rubella and varicella diseases/vaccination.; MedDRA version: 19.0Level: PTClassification code 10028257Term: MumpsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10046980Term: VaricellaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10039252Term: RubellaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10027011Term: MeaslesSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2004-002676-41-LT
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-21
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5754

Inclusion Criteria

- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study.
- Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination.
- Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
- Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
- Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work).
- Subjects:
(1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or
(2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or
(3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or
(4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.

Are the trial subjects under 18? yes
Number of subjects for this age range: 5754
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

- Previous vaccination against measles, mumps, rubella and/or varicella.
- History of previous measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day). Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
- Major congenital defects or serious chronic illness.
- Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterium becomes not applicable, potential study participants may come back at a later stage for study inclusion).
- History of any neurologic disorders or seizures.
- Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.
Additional exclusion criteria for subjects included in the subset:
- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).

Study & Design

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