Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Measles Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Zoster Virus Infection Virus Diseases

Age range

15 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Ancenis, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children must be healthy to participate

Exclusion criteria

Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
Children must not have been vaccinated against varicella.
They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.

Treatment and study plan

MeMuRu-OKA (study vacc)

Biological

MMR, Varicella vacc (control)

Biological

Primary outcomes

Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Secondary outcomes

Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Jul 18, 2006
Registry last updated: Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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