Clinical trial NCT01506193: Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biological's Live Attenuated Measles Mumps Rubella Varicella Vaccine (PriorixTetra™) When Co-administered With Conjugated Meningococcal C Vaccine (Meningitec®, Nuron Biotechs' Vaccine) in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rubella
Varicella
Measles
Mumps
Keywords: safety
healthy
conjugated
immunogenicity
children
MenC vaccine
MMRV vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-09
Enrollment: 716
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
* A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/ LAR of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
* History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
* Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrollment.
* Documented human immunodeficiency virus (HIV) positive subject.
* Any contraindications as stated in the Summary of Product Characteristics.
* Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.

Primary outcomes:
measure: Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
timeFrame: At 42 days after vaccination
measure: Number of Seroprotected Subjects for rSBA-MenC Antibodies
timeFrame: At 42 days after vaccination
Secondary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 15-day (Days 0-14) post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Fever Per Half Degree
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any, Localised and Generalised Rashes
timeFrame: Within the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Within 43 days (Days 0-42) after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout study period (from Day 0 to approximately Month 4)
measure: Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
timeFrame: At Day 42 after vaccination
Other outcomes:
Locations:
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Chiavari
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Cuneo
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Novara
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Alghero (SS)
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Catania
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Modica (RG)
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Ragusa (RG)
country: Italy
facility: GSK Investigational Site
state: Sicilia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Durando P, Esposito S, Bona G, Cuccia M, Desole MG, Ferrera G, Gabutti G, Pellegrino A, Salvini F, Henry O, Povey M, Marchetti F. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy. Vaccine. 2016 Aug 5;34(36):4278-84. doi: 10.1016/j.vaccine.2016.07.009. Epub 2016 Jul 14.