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

Primary Purpose

Rubella, Varicella, Measles

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
PriorixTetra™
Meningitec
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rubella focused on measuring safety, healthy, conjugated, immunogenicity, children, MenC vaccine, MMRV vaccine

Eligibility Criteria

13 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
Number of Seroprotected Subjects for rSBA-MenC Antibodies
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.

Secondary Outcome Measures

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects Reporting Fever Per Half Degree
Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.
Number of Subjects Reporting Any, Localised and Generalised Rashes
Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.

Full Information

First Posted
January 5, 2012
Last Updated
July 11, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01506193
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 6, 2012 (Actual)
Primary Completion Date
February 17, 2014 (Actual)
Study Completion Date
March 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rubella, Varicella, Measles, Mumps
Keywords
safety, healthy, conjugated, immunogenicity, children, MenC vaccine, MMRV vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
716 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
Arm Title
Group B
Arm Type
Experimental
Arm Description
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
Intervention Type
Biological
Intervention Name(s)
PriorixTetra™
Other Intervention Name(s)
MMRV vaccine (GSK208136)
Intervention Description
One dose administered subcutaneously
Intervention Type
Biological
Intervention Name(s)
Meningitec
Other Intervention Name(s)
MenC vaccine
Intervention Description
One dose administered intramuscularly
Primary Outcome Measure Information:
Title
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Description
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.
Time Frame
At 42 days after vaccination
Title
Number of Seroprotected Subjects for rSBA-MenC Antibodies
Description
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
Time Frame
At 42 days after vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 15-day (Days 0-14) post-vaccination period
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects Reporting Fever Per Half Degree
Description
Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects Reporting Any, Localised and Generalised Rashes
Description
Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.
Time Frame
Within the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame
Within 43 days (Days 0-42) after each vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
Throughout study period (from Day 0 to approximately Month 4)
Title
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Description
Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.
Time Frame
At Day 42 after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
GSK Investigational Site
City
Chiavari
State/Province
Liguria
ZIP/Postal Code
16043
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
GSK Investigational Site
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
GSK Investigational Site
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
GSK Investigational Site
City
Alghero (SS)
State/Province
Sardegna
ZIP/Postal Code
07041
Country
Italy
Facility Name
GSK Investigational Site
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09127
Country
Italy
Facility Name
GSK Investigational Site
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
GSK Investigational Site
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95129
Country
Italy
Facility Name
GSK Investigational Site
City
Modica (RG)
State/Province
Sicilia
ZIP/Postal Code
97100
Country
Italy
Facility Name
GSK Investigational Site
City
Ragusa (RG)
State/Province
Sicilia
ZIP/Postal Code
97100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27423382
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.
Results Reference
derived

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

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