NCT05630846

A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

Completed Phase 2 Results posted Last updated 22 June 2025

What this trial tests

Phase 2 trial testing Investigational MMRV(H)NS vaccine in Measles; Mumps; Rubella; Chickenpox in 801 participants. Completed in 14 October 2024.

Timeline

14 December 2022

Primary endpoint
7 June 2024

14 October 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	801
Start date	14 December 2022
Primary completion	7 June 2024
Estimated completion	14 October 2024
Sites	47 locations across Colombia, Taiwan, Puerto Rico, United States, Latvia

Drugs / interventions tested

• Investigational MMRV(H)NS vaccine — full drug profile →
• Investigational MM(H)RVNS vaccine — full drug profile →
• Investigational M(L)M(L)R(L)V(L)NS vaccine — full drug profile →
• Marketed MMRV_Lot 1 and Lot 2 vaccine — full drug profile →

Conditions studied

• Measles; Mumps; Rubella; Chickenpox — all drugs for Measles; Mumps; Rubella; Chickenpox →
• Measles — all drugs for Measles →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 4 to 6, any sex, with Measles; Mumps; Rubella; Chickenpox or Measles. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

GMC of Anti-measles Antibodies at Day 43 Primary · 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

Group	Value	95% CI
MMRV(H)NS Vaccine	801	691 – 928
MM(H)RVNS Vaccine	788	682 – 910
(MMRV)(L)NS Vaccine	728	622 – 852
MMRV_Lot 1 and Lot 2 Pooled Group	682	581 – 801

GMC of Anti-mumps Antibodies at Day 43 Primary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	3369	2976 – 3814
MM(H)RVNS Vaccine	4770	4259 – 5342
(MMRV)(L)NS Vaccine	3114	2771 – 3499
MMRV_Lot 1 and Lot 2 Pooled Group	3176	2830 – 3563

GMC of Anti-rubella Antibodies at Day 43 Primary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	159	145 – 173
MM(H)RVNS Vaccine	178	163 – 195
(MMRV)(L)NS Vaccine	158	144 – 172
MMRV_Lot 1 and Lot 2 Pooled Group	149	137 – 163

GMC of Anti-glycoprotein E (gE) Antibodies at Day 43 Primary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	4229	3723 – 4804
MM(H)RVNS Vaccine	3743	3257 – 4303
(MMRV)(L)NS Vaccine	3369	2934 – 3867
MMRV_Lot 1 and Lot 2 Pooled Group	4002	3493 – 4585

Percentage of Participants With Seroresponse for Measles Antibodies at Day 43 Secondary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	99.4	96.71 – 99.98
MM(H)RVNS Vaccine	98.2	94.96 – 99.64
(MMRV)(L)NS Vaccine	96.3	92.11 – 98.63
MMRV_Lot 1 and Lot 2 Pooled Group	95.2	90.83 – 97.92

Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43 Secondary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	98.8	95.74 – 99.85
MM(H)RVNS Vaccine	100.0	97.87 – 100.0
(MMRV)(L)NS Vaccine	100.0	97.75 – 100.0
MMRV_Lot 1 and Lot 2 Pooled Group	99.4	96.73 – 99.98

Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43 Secondary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	100.0	97.82 – 100.0
MM(H)RVNS Vaccine	100.0	97.87 – 100.0
(MMRV)(L)NS Vaccine	100.0	97.75 – 100.0
MMRV_Lot 1 and Lot 2 Pooled Group	100.0	97.83 – 100.0

Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43 Secondary · 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.

Group	Value	95% CI
MMRV(H)NS Vaccine	100.0	97.85 – 100.0
MM(H)RVNS Vaccine	100.0	97.88 – 100.0
(MMRV)(L)NS Vaccine	100.0	97.79 – 100.0
MMRV_Lot 1 and Lot 2 Pooled Group	100.0	97.84 – 100.0

Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration Secondary · Day 1 to Day 4

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.

Injection site pain

Group	Value	95% CI
MMRV(H)NS Vaccine	76
MM(H)RVNS Vaccine	58
(MMRV)(L)NS Vaccine	64
MMRV_Lot 1 and Lot 2 Pooled Group	76

Redness at injection site

Group	Value	95% CI
MMRV(H)NS Vaccine	41
MM(H)RVNS Vaccine	34
(MMRV)(L)NS Vaccine	26
MMRV_Lot 1 and Lot 2 Pooled Group	42

Swelling at injection site

Group	Value	95% CI
MMRV(H)NS Vaccine	24
MM(H)RVNS Vaccine	21
(MMRV)(L)NS Vaccine	14
MMRV_Lot 1 and Lot 2 Pooled Group	20

Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration Secondary · Day 1 to Day 4

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.

Any drowsiness

Group	Value	95% CI
MMRV(H)NS Vaccine	27
MM(H)RVNS Vaccine	18
(MMRV)(L)NS Vaccine	32
MMRV_Lot 1 and Lot 2 Pooled Group	31

Any loss of appetite

Group	Value	95% CI
MMRV(H)NS Vaccine	20
MM(H)RVNS Vaccine	14
(MMRV)(L)NS Vaccine	22
MMRV_Lot 1 and Lot 2 Pooled Group	26

Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration Secondary · Day 1 to Day 43

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.

Fever

Group	Value	95% CI
MMRV(H)NS Vaccine	27
MM(H)RVNS Vaccine	25
(MMRV)(L)NS Vaccine	25
MMRV_Lot 1 and Lot 2 Pooled Group	27

Any measles/rubella-like rash

Group	Value	95% CI
MMRV(H)NS Vaccine	13
MM(H)RVNS Vaccine	8
(MMRV)(L)NS Vaccine	12
MMRV_Lot 1 and Lot 2 Pooled Group	5

Any varicella-like rash (including injection site)

Group	Value	95% CI
MMRV(H)NS Vaccine	5
MM(H)RVNS Vaccine	6
(MMRV)(L)NS Vaccine	6
MMRV_Lot 1 and Lot 2 Pooled Group	6

Any other rash

Group	Value	95% CI
MMRV(H)NS Vaccine	16
MM(H)RVNS Vaccine	18
(MMRV)(L)NS Vaccine	19
MMRV_Lot 1 and Lot 2 Pooled Group	14

Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration Secondary · Day 1 to Day 43

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

Group	Value	95% CI
MMRV(H)NS Vaccine	44
MM(H)RVNS Vaccine	37
(MMRV)(L)NS Vaccine	48
MMRV_Lot 1 and Lot 2 Pooled Group	53

Adverse events — posted to ClinicalTrials.gov

Time frame: 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. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MMRV(H)NS Vaccine

Serious: 1/198 (1%)

Deaths: 1/198

MM(H)RVNS Vaccine

Serious: 1/200 (1%)

Deaths: 0/200

(MMRV)(L)NS Vaccine

Serious: 1/203 (0%)

Deaths: 0/203

MMRV_Lot 1 and Lot 2 Pooled Group

Serious: 1/195 (1%)

Deaths: 0/195

Serious adverse events (3 terms)

Reaction	System	MMRV(H)NS Vaccine	MM(H)RVNS Vaccine	(MMRV)(L)NS Vaccine	MMRV_Lot 1 and Lot 2 Poole…
Gastroenteritis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Homicide	Social circumstances	—	—	—	—

Other adverse events (110 terms — click to expand)

Reaction	System	MMRV(H)NS Vaccine	MM(H)RVNS Vaccine	(MMRV)(L)NS Vaccine	MMRV_Lot 1 and Lot 2 Poole…
Administration site pain	General disorders	—	—	—	—
Administration site erythema	General disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Rashes, eruptions and exanthems NEC	Skin and subcutaneous tissue disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Administration site swelling	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Injection site erythema	General disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Injection site swelling	General disorders	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
SARS-CoV-2 test positive	Investigations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Conjunctivitis bacterial	Infections and infestations	—	—	—	—
Croup infectious	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Hand-foot-and-mouth disease	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Tympanic membrane perforation	Ear and labyrinth disorders	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—
Anal pruritus	Gastrointestinal disorders	—	—	—	—
Cheilitis	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: Gastroenteritis, Pneumonia, Homicide.

Data from ClinicalTrials.gov NCT05630846 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunogenicity and safety of an investigational quadrivalent measles, mumps, rubella, and varicella vaccine in children aged 4-6 years: A phase II, randomized, multi-country trial.
   Habib MA, Hughes T, Huang LM, Deseda C, et al · · 2026 · PMID 42189573 · DOI 10.1080/21645515.2026.2660525