Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)

Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

* To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC, * To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.

Completed

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Key information

Conditions

Measles Chickenpox DNA Virus Infections Herpesviridae Infections Infections 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 Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy subject of either gender,
Age 12 to 18 months ,
Consent form signed by both parent(s) or by the legal representative properly informed about the study,
Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
Any recent (≤30 days) exposure to measles, mumps or rubella,
Any recent (≤30 days) exposure to varicella or zoster involving:
Any recent (≤3 days) history of febrile illness
Any severe chronic disease,
Active untreated tuberculosis,
Known personal history of seizures,
Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2

Treatment and study plan

M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®

Biological

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Feb 8, 2007
Registry last updated: Oct 18, 2021

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.

Completed