RubellaPhase 3NCT01506193

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

A Phase 3 study testing PriorixTetra™ and Meningitec in people with Rubella and Varicella, run by GlaxoSmithKline at 13 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 13 to 15 monthsHealthy volunteers can take part
Conditions the study is for: Rubella, Varicella, Measles
What is being tested?: PriorixTetra™ and Meningitec
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 716 participants
Where: 13 sitesItaly
Study dates: 6 Feb 2012to 31 Mar 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 15 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Italy13 sites

GSK Investigational Site
Alghero (SS), Sardinia, 07041
GSK Investigational Site
Cagliari, Sardinia, 09127
GSK Investigational Site
Catania, Sicily, 95129
GSK Investigational Site
Chiavari, Liguria, 16043
GSK Investigational Site
Cuneo, Piedmont, 12100
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Modica (RG), Sicily, 97100
GSK Investigational Site
Novara, Piedmont, 28100
GSK Investigational Site
Ragusa (RG), Sicily, 97100
GSK Investigational Site
Rome, Lazio, 00165
GSK Investigational Site
Sassari, Sardinia, 07100

Other trials in Italy

About this study

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

Conditions: Rubella, Varicella, Measles, Mumps
Being tested: PriorixTetra™, Meningitec
Keywords: safety, healthy, conjugated, immunogenicity, children, MenC vaccine, MMRV vaccine
Medical subject headings: Rubella, Chickenpox, Measles, Mumps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PriorixTetra™Biological
Also called MMRV vaccine (GSK208136)
One dose administered subcutaneously
MeningitecBiological
Also called MenC vaccine
One dose administered intramuscularly

Study groups in NCT01506193
Study group	Role	What they receive
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). Receives: Biological: PriorixTetra™; Biological: Meningitec
Group B	Experimental	Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0). Receives: 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). Receives: Biological: PriorixTetra™; Biological: Meningitec

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At 42 days after vaccination

Secondary outcomes (8)

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.
Measured: During the 4-day (Days 0-3) post-vaccination period
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.
Measured: During the 15-day (Days 0-14) post-vaccination period
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.
Measured: During the 43-day (Days 0-42) post-vaccination period
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.
Measured: During the 43-day (Days 0-42) post-vaccination period
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.
Measured: Within the 43-day (Days 0-42) post-vaccination period
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.
Measured: Within 43 days (Days 0-42) after each vaccination
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.
Measured: Throughout study period (from Day 0 to approximately Month 4)
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.
Measured: At Day 42 after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201231 Mar 2014

First posted9 Jan 2012 (estimated)
Study start6 Feb 2012
Primary completion17 Feb 2014
Study completion31 Mar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RubellaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 716 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01506193
Sponsor's protocol ID: 115555
Other IDs: 2011-001608-37
Status last verified: Jun 2017
First submitted: 5 Jan 2012
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 27423382

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01506193
Acronym / sponsor ID: 115555
Conditions: Rubella, Varicella, Measles, Mumps
Keywords: safety, healthy, conjugated, immunogenicity, children, MenC vaccine, MMRV vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 716 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 6 Feb 2012 (actual)
Primary completion: 17 Feb 2014 (actual)
Study completion: 31 Mar 2014 (actual)
First posted: 9 Jan 2012 (estimated)
Results: Posted 9 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Active comparator	Biological: PriorixTetra™, Biological: MeningitecSubjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
Group B	Experimental	Biological: PriorixTetra™, Biological: MeningitecSubjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
Group C	Active comparator	Biological: PriorixTetra™, Biological: MeningitecSubjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).

Who may qualify

Ages: 13 to 15 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PriorixTetra™Also: MMRV vaccine (GSK208136)One dose administered subcutaneously	Biological	Group A, Group B, Group C
MeningitecAlso: MenC vaccineOne dose administered intramuscularly	Biological	Group A, Group B, Group C

Primary outcome

Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Time frame: At 42 days after vaccination
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
Time frame: At 42 days after vaccination
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.

8 secondary outcomes

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Fever Per Half Degree
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any, Localised and Generalised Rashes
Time frame: Within the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 43 days (Days 0-42) after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout study period (from Day 0 to approximately Month 4)
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Time frame: At Day 42 after vaccination

Results and safety

Results posted to the registry on 9 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Priorix-Tetra + Meningitec Group	351	337
Priorix-Tetra Group	183	179
Meningitec Group	182	168

Primary outcome: Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus

Time frame: At 42 days after vaccination. Count of participants. Unit: Participants

Measure	Priorix-Tetra + Meningitec Group n = 309	Priorix-Tetra Group n = 164
Anti-measles ≥ 150 mIU/mL	305	162
Anti-mumps ≥ 231 U/ML	292	151
Anti-rubella ≥ 4 IU/mL	309	164
Anti-varicella ≥ 25 mIU/mL	299	159

Priorix-Tetra + Meningitec Group vs Priorix-Tetra Group: Difference in percentage: -0.04 (95% CI -1.82 to 2.78)
Priorix-Tetra + Meningitec Group vs Priorix-Tetra Group: Difference in percentage: 1.29 (95% CI -3.04 to 6.67)
Priorix-Tetra + Meningitec Group vs Priorix-Tetra Group: Difference in percentage: 0 (95% CI -1.23 to 2.29)

Population analysed: The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.

Primary outcome: Number of Seroprotected Subjects for rSBA-MenC Antibodies

Time frame: At 42 days after vaccination. Count of participants. Unit: Participants

Measure	Priorix-Tetra + Meningitec Group n = 291	Meningitec Group n = 143
Value	286	142

Priorix-Tetra + Meningitec Group vs Meningitec Group: Difference in percentage: -1.02 (95% CI -3.39 to 2.24)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local & general symptoms: during Days 0-3 and Days 0-14 post-vaccination period, respectively; Unsolicited AEs: during the 43 day (Days 0-42) post each vaccination; SAEs: throughout the entire study period (from Day 0 to approximately Month 4).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Priorix-Tetra + Meningitec Group	6 of 351 (1.7%)	327 of 351 (93.2%)	Not reported
Priorix-Tetra Group	4 of 183 (2.2%)	158 of 183 (86.3%)	Not reported
Meningitec Group	2 of 182 (1.1%)	146 of 182 (80.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27423382Durando 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PriorixTetra™ and Meningitec in people with Rubella and Varicella, run by GlaxoSmithKline at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus (time frame: At 42 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.