A Phase 3 interventional study of PriorixTetra™ and Meningitec in Rubella, Varicella and Measles, sponsored by GlaxoSmithKline. Completed at 13 sites in Italy. Open to participants aged 13 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
85 studies on the registry are indexed under Rubella; 11 are open to participants now.
This study's enrollment of 716 is below the median of 801 across 71 interventional studies indexed under Rubella.
Browse Rubella studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
Biological: PriorixTetra™ · Biological: Meningitec
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
Biological: PriorixTetra™ · Biological: Meningitec
One dose administered subcutaneously
Also known as: MMRV vaccine (GSK208136)
One dose administered intramuscularly
Also known as: MenC vaccine
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.
Time frame: 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.
Time frame: At 42 days after vaccination
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 42 after vaccination
| Milestone | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Started | 351 | 183 | 182 |
| Completed | 337 | 179 | 168 |
| Not completed | 14 | 4 | 14 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
| Withdrew: Migrated/moved from study area | 0 | 0 | 1 |
| Withdrew: Adverse event, non-fatal | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 1 | 8 |
| Withdrew: Lost to follow-up | 8 | 3 | 3 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group |
|---|---|---|
| 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 |
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
| Participants | Priorix-Tetra + Meningitec Group | Meningitec Group |
|---|---|---|
| Number of Seroprotected Subjects for rSBA-MenC Antibodies | 286 | 142 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group |
|---|---|---|
| Any Pain, Meningitec | 79 | — |
| Grade 3 Pain, Meningitec | 4 | — |
| Any Pain, Priorix-Tetra | 78 | 31 |
| Grade 3 Pain, Priorix-Tetra | 1 | 1 |
| Any Redness, Meningitec | 100 | — |
| Grade 3 Redness, Meningitec | 9 | — |
| Any Redness, Priorix-Tetra | 92 | 41 |
| Grade 3 Redness, Priorix-Tetra | 4 | 1 |
| Any Swelling, Meningitec | 68 | — |
| Grade 3 Swelling, Meningitec | 9 | — |
| Any Swelling, Priorix-Tetra | 47 | 20 |
| Grade 3 Swelling, Priorix-Tetra | 1 | 2 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Any Drowsiness | 148 | 89 | 56 |
| Grade 3 Drowsiness | 16 | 12 | 6 |
| Related Drowsiness | 128 | 67 | 46 |
| Any Irritability/Fussiness | 187 | 104 | 84 |
| Grade 3 Irritability/Fussiness | 30 | 13 | 7 |
| Related Irritability/Fussiness | 158 | 82 | 64 |
| Any Loss of appetite | 178 | 99 | 60 |
| Grade 3 Loss of appetite | 25 | 12 | 5 |
| Related Loss of appetite | 138 | 75 | 43 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Any Parotid / salivary gland swelling | 3 | 4 | 0 |
| Grade 3 Parotid / salivary gland swelling | 0 | 0 | 0 |
| Related Parotid / salivary gland swelling | 3 | 3 | 0 |
| Any Suspected signs of meningism | 1 | 0 | 1 |
| Grade 3 Suspected signs of meningism | 0 | 0 | 0 |
| Related Suspected signs of meningism | 1 | 0 | 0 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Any temperature | 159 | 86 | 46 |
| Grade 3 temperature | 15 | 9 | 4 |
| Related temperature | 178 | 84 | 28 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Any, Localised or generalised rash | 91 | 41 | 15 |
| Any, With fever rash | 59 | 30 | 2 |
| Any, Varicella like rash | 6 | 1 | 1 |
| Any, Measles/Rubella like rash | 40 | 16 | 2 |
| Any, Grade 3 rash | 2 | 1 | 2 |
| Any, Related rash | 66 | 22 | 6 |
| Localised, Any rash | 43 | 13 | 9 |
| Localised, Administration site rash | 3 | 1 | 3 |
| Localised, Other site rash | 40 | 12 | 6 |
| Localised, With fever rash | 23 | 10 | 1 |
| Localised, Varicella like rash | 2 | 0 | 0 |
| Localised, Measles/Rubella like rash | 15 | 3 | 2 |
| Localised, Grade 3 rash | 0 | 0 | 1 |
| Localised, Related rash | 31 | 4 | 6 |
| Generalised, Any rash | 54 | 28 | 6 |
| Generalised, With fever rash | 38 | 20 | 1 |
| Generalised, Varicella like rash | 4 | 1 | 1 |
| Generalised, Measles/Rubella like rash | 25 | 13 | 0 |
| Generalised, Grade 3 rash | 2 | 1 | 1 |
| Generalised, Related rash | 39 | 18 | 0 |
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.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | 97 | 61 | 41 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 6 | 4 | 2 |
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.
| Titers | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group |
|---|---|---|
| Anti-measles | 2943.6 (2691.5 to 3219.2) | 3158.5 (2749.7 to 3628) |
| Anti-mumps | 1530.7 (1368.4 to 1712.1) | 1591.3 (1346.2 to 1881) |
| Anti-rubella | 40.2 (37.3 to 43.3) | 44.9 (40.6 to 49.6) |
| Anti-varicella | 156.3 (143.9 to 169.8) | 145.2 (129.5 to 162.8) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | — | 6/351 (1.7%) | 327/351 (93.2%) |
| Priorix-Tetra Group | — | 4/183 (2.2%) | 158/183 (86.3%) |
| Meningitec Group | — | 2/182 (1.1%) | 146/182 (80.2%) |
| Event | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| Gastroenteritis rotavirusInfections and infestations | 0/351 | 1/183 | 1/182 |
| Cellulitis orbitalInfections and infestations | 0/351 | 0/183 | 1/182 |
| ArthritisMusculoskeletal and connective tissue disorders | 0/351 | 1/183 | 0/182 |
| GastroenteritisInfections and infestations | 1/351 | 1/183 | 0/182 |
| CellulitisInfections and infestations | 0/351 | 1/183 | 0/182 |
| Staphylococcal infectionInfections and infestations | 0/351 | 1/183 | 0/182 |
| Skull fractured baseInjury, poisoning and procedural complications | 1/351 | 0/183 | 0/182 |
| Febrile convulsionNervous system disorders | 1/351 | 0/183 | 0/182 |
| Loss of consciousnessNervous system disorders | 1/351 | 0/183 | 0/182 |
| DiarrhoeaGastrointestinal disorders | 1/351 | 0/183 | 0/182 |
| Event | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group |
|---|---|---|---|
| PyrexiaGeneral disorders | 220/351 | 114/183 | 64/182 |
| Irritability postvaccinalGeneral disorders | 187/351 | 104/183 | 84/182 |
| Decreased appetiteGeneral disorders | 178/351 | 99/183 | 60/182 |
| SomnolenceNervous system disorders | 148/351 | 89/183 | 56/182 |
| Injection site erythemaGeneral disorders | 121/351 | 41/183 | 0/182 |
| Injection site painGeneral disorders | 92/351 | 31/183 | 0/182 |
| RashSkin and subcutaneous tissue disorders | 91/351 | 41/183 | 15/182 |
| Injection site swellingGeneral disorders | 79/351 | 20/183 | 1/182 |
| CoughRespiratory, thoracic and mediastinal disorders | 11/351 | 10/183 | 5/182 |
| DiarrhoeaGastrointestinal disorders | 11/351 | 10/183 | 4/182 |
| Age, Continuous(Months) | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group | Total |
|---|---|---|---|---|
| Mean | 13.4 ± 0.6 | 13.4 ± 0.6 | 13.4 ± 0.7 | 13.4 ± 0.63 |
| Sex: Female, Male(Participants) | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group | Total |
|---|---|---|---|---|
| Female | 167 | 85 | 88 | 340 |
| Male | 184 | 98 | 94 | 376 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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