Trial Outcomes & Findings for A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age (NCT NCT05084508)

Last Updated: 2025-02-28

Results Overview

Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

800 participants

Primary outcome timeframe

At Day 43

Results posted on

2025-02-28

Participant Flow

Out of 800 participants enrolled, 9 participants discontinued before receiving the vaccination and therefore only 791 participants were included in the Exposed Set and started the study.

* The Prevnar 13 vaccine was administered only to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12- 15 months as per national immunization schedule. * As described in the protocol and analysis plan, participants in the varicella vaccine (VV) group are randomized into two lots (VV\_Lot1 and VV\_Lot2) and analyzed as pooled throughout the study.

Participant milestones

Participant milestones
Measure	VNS_Low Group Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Overall Study STARTED	203	195	203	190
Overall Study COMPLETED	197	190	193	185
Overall Study NOT COMPLETED	6	5	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	VNS_Low Group Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Overall Study Lost to Follow-up	6	3	7	3
Overall Study Withdrawal by Subject	0	2	3	1
Overall Study Other	0	0	0	1

Baseline Characteristics

A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	Total n=791 Participants Total of all reporting groups
Age, Categorical <=18 years	203 Participants n=5 Participants	195 Participants n=7 Participants	203 Participants n=5 Participants	190 Participants n=4 Participants	791 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	102 Participants n=7 Participants	101 Participants n=5 Participants	107 Participants n=4 Participants	424 Participants n=21 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	93 Participants n=7 Participants	102 Participants n=5 Participants	83 Participants n=4 Participants	367 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	75 Participants n=5 Participants	71 Participants n=7 Participants	74 Participants n=5 Participants	73 Participants n=4 Participants	293 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic nor Latino	128 Participants n=5 Participants	124 Participants n=7 Participants	128 Participants n=5 Participants	117 Participants n=4 Participants	497 Participants n=21 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Day 43

Population: The analysis was performed on the Per Protocol Set (PPS), which included participants who received all study interventions as per protocol, were not unblinded, had immunogenicity results post-dose, complied with blood draw intervals, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=171 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=159 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=158 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=161 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies	960 mlU/ml Interval 843.0 to 1093.0	1071 mlU/ml Interval 952.0 to 1204.0	1555 mlU/ml Interval 1407.0 to 1718.0	1284 mlU/ml Interval 1136.0 to 1453.0

SECONDARY outcome

Timeframe: At Day 43

Population: The analysis was performed on the PPS, which included participants who received all study interventions as per protocol, were not unblinded, had immunogenicity results post-dose, complied with blood draw intervals, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL for each group.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=171 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=159 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=158 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=161 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Percentage of Participants With Seroresponse to VZV gE	93.6 Percentage of participants Interval 88.78 to 96.75	96.2 Percentage of participants Interval 91.97 to 98.6	98.7 Percentage of participants Interval 95.5 to 99.85	98.1 Percentage of participants Interval 94.65 to 99.61

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 4

Population: The analysis was performed on the Exposed set (ES), which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.

Assessed solicited administration site events included injection site redness, pain and swelling.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Number of Participants Reporting Each Solicited Administration Site Events Injection site pain	76 Participants	64 Participants	70 Participants	57 Participants
Number of Participants Reporting Each Solicited Administration Site Events Redness at injection site	24 Participants	23 Participants	35 Participants	23 Participants
Number of Participants Reporting Each Solicited Administration Site Events Swelling at injection site	14 Participants	11 Participants	15 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 43

Population: The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.

Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature \>= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Number of Participants Reporting Each Solicited Systemic Events Fever	49 Participants	48 Participants	59 Participants	44 Participants
Number of Participants Reporting Each Solicited Systemic Events Any varicella-like rash	33 Participants	31 Participants	35 Participants	29 Participants
Number of Participants Reporting Each Solicited Systemic Events Any general rash	66 Participants	51 Participants	68 Participants	59 Participants

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 15

Population: The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.

Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Number of Participants Reporting Each Solicited Systemic Events Any irritability	112 Participants	94 Participants	112 Participants	109 Participants
Number of Participants Reporting Each Solicited Systemic Events Any drowsiness	86 Participants	68 Participants	93 Participants	80 Participants
Number of Participants Reporting Each Solicited Systemic Events Any loss of appetite	69 Participants	57 Participants	71 Participants	60 Participants

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 43

Population: The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.

Unsolicited adverse events (AEs) included any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Number of Participants Reporting Unsolicited Adverse Events	67 Participants	53 Participants	64 Participants	61 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 181 (Study end)

Population: The analysis was performed on the ES, which included all participants who received a study intervention. Analysis per group was based on the varicella intervention administered.

A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment.

Outcome measures

Outcome measures
Measure	VNS_Low Group n=203 Participants Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 Participants Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 Participants Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 Participants Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Number of Participants Reporting Serious Adverse Events (SAEs)	2 Participants	4 Participants	4 Participants	6 Participants

Adverse Events

VNS_Low Group

Serious events: 2 serious events

Other events: 173 other events

Deaths: 0 deaths

VNS_Med Group

Serious events: 4 serious events

Other events: 165 other events

Deaths: 0 deaths

VNS_High Group

Serious events: 4 serious events

Other events: 178 other events

Deaths: 0 deaths

VV_Lot1 and Lot2 Pooled Group

Serious events: 6 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VNS_Low Group n=203 participants at risk Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1\.	VNS_Med Group n=195 participants at risk Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VNS_High Group n=203 participants at risk Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.	VV_Lot1 and Lot2 Pooled Group n=190 participants at risk Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Infections and infestations Adenovirus infection	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Bronchiolitis	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	1.1% 2/190 • Number of events 2 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Croup infectious	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Influenza	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Pharyngitis	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Pneumonia	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	1.0% 2/195 • Number of events 2 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Respiratory syncytial virus infection	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Infections and infestations Viral infection	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.51% 1/195 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Metabolism and nutrition disorders Dehydration	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Nervous system disorders Dyskinesia	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.51% 1/195 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.49% 1/203 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/190 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/195 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.00% 0/203 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43	0.53% 1/190 • Number of events 1 • SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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