A Phase 2 interventional study of Investigational MMRV(H)NS vaccine and Investigational MM(H)RVNS vaccine in Measles; Mumps; Rubella; Chickenpox and Measles, sponsored by GlaxoSmithKline. Completed at 47 sites in 5 countries. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared with the licensed measles, mumps, rubella, varicella vaccine, ProQuad (referred to as the MMRV vaccine), when given as a second dose to children 4 to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).
This study will evaluate immunogenicity and safety using 3 MMRVNS formulations which vary for some or all the individual virus potencies. The 3 MMRVNS formulations (designated as MMRV(H)NS vaccine, MM(H)RVNS vaccine and M(L)M(L)R(L)V(L)NS vaccine) will be compared with the MMRV vaccine. To ensure representative data on the comparator, participants enrolled in the MMRV group will be randomized to two different lots (designated as MMRV_Lot 1 and MMRV_Lot 2). Throughout the study, the two lots will be analyzed as a pooled group.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 801 is close to the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles 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.
Counted across the registry records on this site, refreshed daily.
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:
Medical Conditions
Prior and Concomitant Therapy
Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3), with the exception of:
Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter.
Prior/Concurrent Clinical Study Experience
Other Exclusions
Participants with the following high-risk individuals in their household:
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.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.
Biological: Investigational MMRV(H)NS vaccine
Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.
Biological: Investigational MM(H)RVNS vaccine
Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine
Participants receive a single dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.
Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine
1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Drug page: Measles, mumps, rubella, varicella vaccine
1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.
Also known as: ProQuad
GMC of Anti-measles Antibodies at Day 43
Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
GMC of Anti-mumps Antibodies at Day 43
Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
GMC of Anti-rubella Antibodies at Day 43
Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43
Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
Percentage of Participants With Seroresponse for Measles Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 measles antibodies concentration was \>=116 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 mumps antibodies concentration was \>=296 AU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 rubella antibodies concentration was \>=24 IU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 varicella antibodies concentration was \>=300 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Time frame: At Day 43
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration
The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Analysis was performed on exposed set which included all participants who received a study intervention. Only those participants with solicited AEs were included in this analysis.
Time frame: Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration
The solicited systemic events after vaccination included drowsiness and loss of appetite. Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Time frame: Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration
The solicited systemic events after vaccination included fever, measles/rubella-like rash, varicella- like rash and other rash (not measles/rubella-like rash or varicella-like rash). Fever was defined as temperature greater than or equal to 38.0 degrees Celsius (100.4 degrees Fahrenheit) by any route (the preferred location for measuring temperature is the axilla). Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Time frame: Day 1 to Day 43
Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or was included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events. Unsolicited AEs must have been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious adverse events (SAEs) and non-serious AEs. Analysis was performed on exposed set.
Time frame: Day 1 to Day 43
Number of Participants With SAEs After Vaccine Dose Administration
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or other significant medical events. Analysis was performed on exposed set.
Time frame: Throughout the study period (Day 1 to Day 181)
Out of the 801 participants enrolled, 796 were included in the Exposed set and started the study.
| Milestone | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Started | 198 | 200 | 203 | 195 |
| Completed | 187 | 192 | 197 | 189 |
| Not completed | 11 | 8 | 6 | 6 |
| Withdrew: Death | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 | 4 | 1 |
| Withdrew: Lost to follow-up | 6 | 5 | 2 | 5 |
| Withdrew: Other | 1 | 0 | 0 | 0 |
Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.
| mIU/mL | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| GMC of Anti-measles Antibodies at Day 43 | 801 ± 691 | 788 ± 682 | 728 ± 622 | 682 ± 581 |
Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| AU/mL | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| GMC of Anti-mumps Antibodies at Day 43 | 3369 ± 2976 | 4770 ± 4259 | 3114 ± 2771 | 3176 ± 2830 |
Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| IU/mL | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| GMC of Anti-rubella Antibodies at Day 43 | 159 ± 145 | 178 ± 163 | 158 ± 144 | 149 ± 137 |
Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| mIU/mL | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| GMC of Anti-glycoprotein E (gE) Antibodies at Day 43 | 4229 ± 3723 | 3743 ± 3257 | 3369 ± 2934 | 4002 ± 3493 |
Seroresponse was defined as the participants of participants for whom the Day 43 measles antibodies concentration was \>=116 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| Percentage of participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Percentage of Participants With Seroresponse for Measles Antibodies at Day 43 | 99.4 ± 96.71 | 98.2 ± 94.96 | 96.3 ± 92.11 | 95.2 ± 90.83 |
Seroresponse was defined as the participants of participants for whom the Day 43 mumps antibodies concentration was \>=296 AU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| Percentage of participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43 | 98.8 ± 95.74 | 100.0 ± 97.87 | 100.0 ± 97.75 | 99.4 ± 96.73 |
Seroresponse was defined as the participants of participants for whom the Day 43 rubella antibodies concentration was \>=24 IU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| Percentage of participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43 | 100.0 ± 97.82 | 100.0 ± 97.87 | 100.0 ± 97.75 | 100.0 ± 97.83 |
Seroresponse was defined as the participants of participants for whom the Day 43 varicella antibodies concentration was \>=300 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| Percentage of participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43 | 100.0 ± 97.85 | 100.0 ± 97.88 | 100.0 ± 97.79 | 100.0 ± 97.84 |
The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Analysis was performed on exposed set which included all participants who received a study intervention. Only those participants with solicited AEs were included in this analysis.
| Participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Injection site pain | 76 | 58 | 64 | 76 |
| Redness at injection site | 41 | 34 | 26 | 42 |
| Swelling at injection site | 24 | 21 | 14 | 20 |
The solicited systemic events after vaccination included drowsiness and loss of appetite. Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
| Participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Any drowsiness | 27 | 18 | 32 | 31 |
| Any loss of appetite | 20 | 14 | 22 | 26 |
The solicited systemic events after vaccination included fever, measles/rubella-like rash, varicella- like rash and other rash (not measles/rubella-like rash or varicella-like rash). Fever was defined as temperature greater than or equal to 38.0 degrees Celsius (100.4 degrees Fahrenheit) by any route (the preferred location for measuring temperature is the axilla). Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
| Participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Fever | 27 | 25 | 25 | 27 |
| Any measles/rubella-like rash | 13 | 8 | 12 | 5 |
| Any varicella-like rash (including injection site) | 5 | 6 | 6 | 6 |
| Any other rash | 16 | 18 | 19 | 14 |
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or was included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events. Unsolicited AEs must have been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious adverse events (SAEs) and non-serious AEs. Analysis was performed on exposed set.
| Participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration | 44 | 37 | 48 | 53 |
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or other significant medical events. Analysis was performed on exposed set.
| Participants | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Number of Participants With SAEs After Vaccine Dose Administration | 1 | 1 | 1 | 1 |
Collected over Solicited administration site and systemic events (drowsiness, loss of appetite): Day 1 to 4; solicited systemic events (fever, measles/rubella like rash, varicella-like rash and other rash); and unsolicited AEs: Day 1 to 43; SAEs: Day 1 to 181. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MMRV(H)NS Vaccine | 1/198 (0.5%) | 1/198 (0.5%) | 127/198 (64.1%) |
| MM(H)RVNS Vaccine | 0/200 (0%) | 1/200 (0.5%) | 114/200 (57%) |
| (MMRV)(L)NS Vaccine | 0/203 (0%) | 1/203 (0.5%) | 126/203 (62.1%) |
| MMRV_Lot 1 and Lot 2 Pooled Group | 0/195 (0%) | 1/195 (0.5%) | 132/195 (67.7%) |
| Event | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| GastroenteritisInfections and infestations | 0/198 | 0/200 | 0/203 | 1/195 |
| HomicideSocial circumstances | 1/198 | 0/200 | 0/203 | 0/195 |
| PneumoniaInfections and infestations | 0/198 | 1/200 | 1/203 | 0/195 |
| Event | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group |
|---|---|---|---|---|
| Administration site painGeneral disorders | 76/198 | 58/200 | 64/203 | 76/195 |
| Administration site erythemaGeneral disorders | 41/198 | 34/200 | 26/203 | 42/195 |
| SomnolenceNervous system disorders | 27/198 | 18/200 | 32/203 | 32/195 |
| PyrexiaGeneral disorders | 27/198 | 25/200 | 25/203 | 27/195 |
| Decreased appetiteMetabolism and nutrition disorders | 20/198 | 14/200 | 22/203 | 26/195 |
| Rashes, eruptions and exanthems NECSkin and subcutaneous tissue disorders | 24/198 | 23/200 | 27/203 | 17/195 |
| Administration site swellingGeneral disorders | 24/198 | 21/200 | 14/203 | 20/195 |
| Upper respiratory tract infectionInfections and infestations | 9/198 | 7/200 | 7/203 | 10/195 |
| NasopharyngitisInfections and infestations | 2/198 | 2/200 | 5/203 | 5/195 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/198 | 2/200 | 1/203 | 5/195 |
| Age, Continuous(years) | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group | Total |
|---|---|---|---|---|---|
| Mean | 4.2 ± 0.4 | 4.2 ± 0.5 | 4.2 ± 0.5 | 4.2 ± 0.5 | 4.2 ± 0.5 |
| Sex: Female, Male(Participants) | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group | Total |
|---|---|---|---|---|---|
| Female | 73 | 85 | 105 | 99 | 362 |
| Male | 125 | 115 | 98 | 96 | 434 |
| Race (NIH/OMB)(Participants) | MMRV(H)NS Vaccine | MM(H)RVNS Vaccine | (MMRV)(L)NS Vaccine | MMRV_Lot 1 and Lot 2 Pooled Group | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 34 | 33 | 33 | 33 | 133 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 25 | 36 | 33 | 37 | 131 |
| White | 123 | 113 | 115 | 109 | 460 |
| More than one race | 15 | 17 | 19 | 15 | 66 |
| Unknown or Not Reported | 1 | 1 | 3 | 1 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.gsk-studyregister.com
Ran from Dec 2022 to primary completion in Jun 2024, 17 months.
Results were first posted in Jun 2025, 1 year after primary completion.
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