Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

NCT01506193 | Completed Phase 3 Results

• 2 other identifiers: 1155552011-001608-37
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 13

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.

Conditions

Rubella; Varicella; Measles; Mumps

Keywords

safety; healthy; conjugated; immunogenicity; children; MenC vaccine; MMRV vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus

  Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.

  At 42 days after vaccination

• Number of Seroprotected Subjects for rSBA-MenC Antibodies

  Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.

  At 42 days after vaccination

Secondary Outcomes (8)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

  During the 15-day (Days 0-14) post-vaccination period

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

  During the 43-day (Days 0-42) post-vaccination period

• Number of Subjects Reporting Fever Per Half Degree

  During the 43-day (Days 0-42) post-vaccination period

• Number of Subjects Reporting Any, Localised and Generalised Rashes

  Within the 43-day (Days 0-42) post-vaccination period

Study Arms (3)

Group A

ACTIVE COMPARATOR

Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).

Biological: PriorixTetra™; Biological: Meningitec

Group B

EXPERIMENTAL

Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).

Biological: PriorixTetra™; Biological: Meningitec

Group C

ACTIVE COMPARATOR

Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).

Biological: PriorixTetra™; Biological: Meningitec

Interventions

PriorixTetra™ BIOLOGICAL

One dose administered subcutaneously

Also known as: MMRV vaccine (GSK208136)

Group A; Group B; Group C

Meningitec BIOLOGICAL

One dose administered intramuscularly

Also known as: MenC vaccine

Group A; Group B; Group C

Eligibility Criteria

• Age: 13 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Rome, Lazio, 00165, Italy

Location

GSK Investigational Site

Chiavari, Liguria, 16043, Italy

Location

GSK Investigational Site

Genoa, Liguria, 16132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20122, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20142, Italy

Location

GSK Investigational Site

Cuneo, Piedmont, 12100, Italy

Location

GSK Investigational Site

Novara, Piedmont, 28100, Italy

Location

GSK Investigational Site

Alghero (SS), Sardinia, 07041, Italy

Location

GSK Investigational Site

Cagliari, Sardinia, 09127, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Catania, Sicily, 95129, Italy

Location

GSK Investigational Site

Modica (RG), Sicily, 97100, Italy

Location

GSK Investigational Site

Ragusa (RG), Sicily, 97100, Italy

Location

Related Publications (1)

• 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.

  PMID: 27423382 DERIVED

MeSH Terms

Conditions

Rubella; Chickenpox; Measles; Mumps

Interventions

measles, mumps, rubella, varicella vaccine; MenC-CRM vaccine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 9, 2012
• Study Start: February 6, 2012
• Primary Completion: February 17, 2014
• Study Completion: March 31, 2014
• Last Updated: August 17, 2018
• Results First Posted: January 9, 2017

Record last verified: 2017-06

Locations

IT (13)