Trial Outcomes & Findings for 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 (NCT NCT05630846)

Last Updated: 2025-06-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

801 participants

Primary outcome timeframe

At Day 43

Results posted on

2025-06-22

Participant Flow

Out of the 801 participants enrolled, 796 were included in the Exposed set and started the study.

The participants enrolled in the measles, mumps, rubella, and varicella vaccine (investigational vaccine) (MMRVNS) groups were randomized to 3 formulations which varied in some or all the individual viral potencies. Participants enrolled in the measles, mumps, rubella, and varicella vaccine (comparator vaccine) (MMRV) group were randomized to 2 different lots. Throughout the study, the 2 lots were analyzed as a pooled group.

Participant milestones

Participant milestones
Measure	MMRV(H)NS Vaccine Participants received a single dose of measles,mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.	MM(H)RVNS Vaccine Participants received a single dose of measles,rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.	(MMRV)(L)NS Vaccine Participants received a single dose of MMR and VNS, all at low (L) potency vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Overall Study STARTED	198	200	203	195
Overall Study COMPLETED	187	192	197	189
Overall Study NOT COMPLETED	11	8	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	MMRV(H)NS Vaccine Participants received a single dose of measles,mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.	MM(H)RVNS Vaccine Participants received a single dose of measles,rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.	(MMRV)(L)NS Vaccine Participants received a single dose of MMR and VNS, all at low (L) potency vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Overall Study Death	1	0	0	0
Overall Study Withdrawal by Subject	3	3	4	1
Overall Study Lost to Follow-up	6	5	2	5
Overall Study Other	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a singledose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.	Total n=796 Participants Total of all reporting groups
Age, Continuous	4.2 years STANDARD_DEVIATION 0.4 • n=93 Participants	4.2 years STANDARD_DEVIATION 0.5 • n=4 Participants	4.2 years STANDARD_DEVIATION 0.5 • n=27 Participants	4.2 years STANDARD_DEVIATION 0.5 • n=483 Participants	4.2 years STANDARD_DEVIATION 0.5 • n=36 Participants
Sex: Female, Male Female	73 Participants n=93 Participants	85 Participants n=4 Participants	105 Participants n=27 Participants	99 Participants n=483 Participants	362 Participants n=36 Participants
Sex: Female, Male Male	125 Participants n=93 Participants	115 Participants n=4 Participants	98 Participants n=27 Participants	96 Participants n=483 Participants	434 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	34 Participants n=93 Participants	33 Participants n=4 Participants	33 Participants n=27 Participants	33 Participants n=483 Participants	133 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	25 Participants n=93 Participants	36 Participants n=4 Participants	33 Participants n=27 Participants	37 Participants n=483 Participants	131 Participants n=36 Participants
Race (NIH/OMB) White	123 Participants n=93 Participants	113 Participants n=4 Participants	115 Participants n=27 Participants	109 Participants n=483 Participants	460 Participants n=36 Participants
Race (NIH/OMB) More than one race	15 Participants n=93 Participants	17 Participants n=4 Participants	19 Participants n=27 Participants	15 Participants n=483 Participants	66 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	6 Participants n=36 Participants

PRIMARY outcome

Timeframe: At Day 43

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
GMC of Anti-measles Antibodies at Day 43	801 mIU/mL 95% Confidence Interval 691 • Interval 691.0 to 928.0	788 mIU/mL 95% Confidence Interval 682 • Interval 682.0 to 910.0	728 mIU/mL 95% Confidence Interval 622 • Interval 622.0 to 852.0	682 mIU/mL 95% Confidence Interval 581 • Interval 581.0 to 801.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
GMC of Anti-mumps Antibodies at Day 43	3369 AU/mL 95% Confidence Interval 2976 • Interval 2976.0 to 3814.0	4770 AU/mL 95% Confidence Interval 4259 • Interval 4259.0 to 5342.0	3114 AU/mL 95% Confidence Interval 2771 • Interval 2771.0 to 3499.0	3176 AU/mL 95% Confidence Interval 2830 • Interval 2830.0 to 3563.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
GMC of Anti-rubella Antibodies at Day 43	159 IU/mL 95% Confidence Interval 145 • Interval 145.0 to 173.0	178 IU/mL 95% Confidence Interval 163 • Interval 163.0 to 195.0	158 IU/mL 95% Confidence Interval 144 • Interval 144.0 to 172.0	149 IU/mL 95% Confidence Interval 137 • Interval 137.0 to 163.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=170 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=172 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=165 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=169 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43	4229 mIU/mL 95% Confidence Interval 3723 • Interval 3723.0 to 4804.0	3743 mIU/mL 95% Confidence Interval 3257 • Interval 3257.0 to 4303.0	3369 mIU/mL 95% Confidence Interval 2934 • Interval 2934.0 to 3867.0	4002 mIU/mL 95% Confidence Interval 3493 • Interval 3493.0 to 4585.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Percentage of Participants With Seroresponse for Measles Antibodies at Day 43	99.4 Percentage of participants 95% Confidence Interval 96.71 • Interval 96.71 to 99.98	98.2 Percentage of participants 95% Confidence Interval 94.96 • Interval 94.96 to 99.64	96.3 Percentage of participants 95% Confidence Interval 92.11 • Interval 92.11 to 98.63	95.2 Percentage of participants 95% Confidence Interval 90.83 • Interval 90.83 to 97.92

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43	98.8 Percentage of participants 95% Confidence Interval 95.74 • Interval 95.74 to 99.85	100.0 Percentage of participants 95% Confidence Interval 97.87 • Interval 97.87 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.75 • Interval 97.75 to 100.0	99.4 Percentage of participants 95% Confidence Interval 96.73 • Interval 96.73 to 99.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=167 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=171 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=162 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=168 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43	100.0 Percentage of participants 95% Confidence Interval 97.82 • Interval 97.82 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.87 • Interval 97.87 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.75 • Interval 97.75 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.83 • Interval 97.83 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=170 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=172 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=165 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=169 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43	100.0 Percentage of participants 95% Confidence Interval 97.85 • Interval 97.85 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.88 • Interval 97.88 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.79 • Interval 97.79 to 100.0	100.0 Percentage of participants 95% Confidence Interval 97.84 • Interval 97.84 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration Injection site pain	76 Participants	58 Participants	64 Participants	76 Participants
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration Redness at injection site	41 Participants	34 Participants	26 Participants	42 Participants
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration Swelling at injection site	24 Participants	21 Participants	14 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration Any loss of appetite	20 Participants	14 Participants	22 Participants	26 Participants
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration Any drowsiness	27 Participants	18 Participants	32 Participants	31 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration Any measles/rubella-like rash	13 Participants	8 Participants	12 Participants	5 Participants
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration Any varicella-like rash (including injection site)	5 Participants	6 Participants	6 Participants	6 Participants
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration Fever	27 Participants	25 Participants	25 Participants	27 Participants
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration Any other rash	16 Participants	18 Participants	19 Participants	14 Participants

SECONDARY outcome

Timeframe: 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 (SAEs) and non-serious AEs. Analysis was performed on exposed set.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration	44 Participants	37 Participants	48 Participants	53 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Day 181)

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.

Outcome measures

Outcome measures
Measure	MMRV(H)NS Vaccine n=198 Participants Participants received a single dose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 Participants Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 Participants Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 Participants Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Number of Participants With SAEs After Vaccine Dose Administration	1 Participants	1 Participants	1 Participants	1 Participants

Adverse Events

MMRV(H)NS Vaccine

Serious events: 1 serious events

Other events: 127 other events

Deaths: 1 deaths

MM(H)RVNS Vaccine

Serious events: 1 serious events

Other events: 114 other events

Deaths: 0 deaths

(MMRV)(L)NS Vaccine

Serious events: 1 serious events

Other events: 126 other events

Deaths: 0 deaths

MMRV_Lot 1 and Lot 2 Pooled Group

Serious events: 1 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MMRV(H)NS Vaccine n=198 participants at risk Participants received a singledose of MMRV(H)NS vaccine on Day1.	MM(H)RVNS Vaccine n=200 participants at risk Participants received a single dose of MM(H)RVNS vaccine on Day 1.	(MMRV)(L)NS Vaccine n=203 participants at risk Participants received a single dose of M(L)M(L)R(L)V(L)NS vaccine on Day 1.	MMRV_Lot 1 and Lot 2 Pooled Group n=195 participants at risk Participants received a single dose of a marketed MMRV vaccine from Lot 1 or Lot 2 on Day 1.
Infections and infestations Gastroenteritis	0.00% 0/198 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/200 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/203 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.51% 1/195 • Number of events 1 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Pneumonia	0.00% 0/198 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.50% 1/200 • Number of events 2 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.49% 1/203 • Number of events 1 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/195 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Social circumstances Homicide	0.51% 1/198 • Number of events 1 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/200 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/203 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/195 • 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 Solicited and unsolicited events were reported per participant/parent at any dose for the assessed timeframe (within 43 days after vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline Biologicals SA

Phone: 8664357343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER