Safety and Immunogenicity of Two Intradermal Rabies Vacci... | NCT02177032

ID	Type	Description	Link
2013-CT0191	Registry Identifier	registry.healthresearch.ph

Name	Class
Novartis Vaccines	INDUSTRY

Safety and Immunogenicity of Two Intradermal Rabies Vacci... | NCT02177032 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4-sites, 1-week without HRIG	Experimental	PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen	Biological: Rabies vaccine
4-sites, 1-week with HRIG	Experimental	PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG	Biological: Rabies vaccines + Rabies immunoglobulins
2-sites, TRC without HRIG	Active Comparator	PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen	Biological: Rabies vaccine
2-sites, TRC with HRIG	Active Comparator	PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG	Biological: Rabies vaccines + Rabies immunoglobulins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rabies vaccine	Biological	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)	Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.	Study day 50 (D50)

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs	Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males and females ≥ 1 years of age
Individuals/ individual's parents or legal guardians who have given written consent
Individuals in good health
Individuals who can comply with study procedures

Exclusion Criteria:

Behavioral or cognitive impairment or psychiatric disease.
Unable to comprehend and to follow all required study procedures for the whole period of the study.
History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
Female of childbearing potential, with a positive pregnancy test prior to enrollment.
Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
Allergic to any of the vaccine components.
Allergic to any of the human rabies immunoglobulin components.
Contraindication or precaution against rabies vaccination.
Contraindication or precaution against man rabies immunoglobulin administration.
Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
Part of the study personnel or immediate family members of study personnel conducting this study.
Current or history of drug or alcohol abuse within the past 2 years.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
4, De La Salle Health Sciences Institute		Cavite		4114	Philippines
1, Research Institute for Tropical Medicine

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
FG001	4-sites, 1-week WITH HRIG

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
ADMINISTRATIVE REASON		FG0002 subjects FG0010 subjects FG0021 subjects FG0030 subjects
Lost to Follow-up		FG0000 subjects FG0012 subjects FG0020 subjects FG0030 subjects
OTHER		FG0002 subjects FG0010 subjects FG0021 subjects FG0030 subjects
Withdrawal by Subject		FG0001 subjects FG0010 subjects FG0021 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
BG001	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
BG002	2-sites, TRC WITHOUT HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.
BG003	2-sites, TRC WITH HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000355 BG00188 BG002354 BG00388 BG004885

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

year

Title

Denominators

Categories

Title	Measurements
	BG00020.0± 15.0 BG00132.7± 10.8 BG00220.6± 15.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
FEMALE	BG000202 BG00144 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)

Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.

Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Study day 50 (D50)

ID	Title	Description
OG000	TOTAL 4-sites, 1-week	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1
OG001	TOTAL 2-sites, TRC	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1

Units	Counts
Participants	OG000357 OG001350

Title

Denominators

Categories

Title	Measurements
	OG00099(98 to 100) OG001100(99 to 100)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact				Protection Rate Differences	-1			2-Sided	95	-2.4	0					Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is > -0.05 (non-inferiority margin).

Secondary

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs

Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.

Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Study Day 50

ID	Title	Description
OG000	TOTAL 4-sites, 1-week	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
OG001	TOTAL 2-sites, TRC

Secondary

Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Days 8, 15, 91, 181 and 366

ID	Title	Description
OG000	TOTAL 4-sites, 1-week	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1

Secondary

Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age

Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.

RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.

Posted

Number

95% Confidence Interval

Percentages of Subjects

At Days 8, 15, 91, 181 and 366

ID	Title	Description
OG000	TOTAL 4-sites, 1-week	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
OG001	TOTAL 2-sites, TRC	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1

Secondary

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.

RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Days 8, 15, 50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG001	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen

Secondary

Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.

Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

Posted

Number

95% Confidence Interval

Percentages of Subjects

At Days 8, 15,50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG001	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen

Secondary

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Days 8, 15, 50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week Without HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
OG001	2-sites, TRC Without HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.

Units	Counts
Participants

Secondary

Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age

Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.

Posted

Number

95% Confidence Interval

Percentages of Subjects

At Days 8, 15, 50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week Without HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
OG001	2-sites, TRC Without HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.

Units	Counts
Participants

Secondary

Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.

Posted

Number

Subjects

From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)

ID	Title	Description
OG000	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
OG001	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG002	2-sites, TRC WITHOUT HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.

Posted

Number

Subjects

Day 1 to Day 366

ID	Title	Description
OG000	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen
OG001	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG002	2-sites, TRC WITHOUT HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen
OG003

Secondary

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Days 8, 15, 50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG001	2-sites TRC WITH HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1

Secondary

Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups

Posted

Number

95% Confidence Interval

Percentages of Subjects

At Days 8, 15,50, 91, 181 and 366

ID	Title	Description
OG000	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
OG001	2-sites, TRC WITH HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	4-sites, 1-week WITHOUT HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen	5	356	292	356
EG001	4-sites, 1-week WITH HRIG	12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight	1	85	78	85
EG002	2-sites, TRC WITHOUT HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.	4	353	298	353
EG003	2-sites, TRC WITH HRIG	8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly	2	89	82	89

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG0030 affected89 at risk
Angina Unstable	Cardiac disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Pyrexia	General disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Appendiceal Abscess	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0011 affected85 at risk EG0020 affected353 at risk EG003
Appendicitis Perforated	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Dengue Fever	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0011 affected85 at risk EG0021 affected353 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
HIV Infection	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Hand-Foot-And-Mouth Disease	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Influenza	Immune system disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Pneumonia	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Pseudomonal Sepsis	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0011 affected85 at risk EG0021 affected353 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Animal Bite	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0005 affected356 at risk EG0010 affected85 at risk EG0024 affected353 at risk EG003
Animal Scratch	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0022 affected353 at risk EG003
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003
Dysfunctional Uterine Bleeding	Reproductive system and breast disorders	MedDRA (17.0)	Non-systematic Assessment	EG0001 affected356 at risk EG0010 affected85 at risk EG0020 affected353 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Non-systematic Assessment	EG0000 affected356 at risk EG0010 affected85 at risk EG0021 affected353 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00028 affected356 at risk EG0018 affected85 at risk EG00220 affected353 at risk EG0038 affected89 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00022 affected356 at risk EG0014 affected85 at risk EG00212 affected353 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00015 affected356 at risk EG0011 affected85 at risk EG00220 affected353 at risk EG003
CHILLS	General disorders	MedDRA (17.0)	Systematic Assessment	EG00015 affected356 at risk EG0014 affected85 at risk EG00213 affected353 at risk EG003
FATIGUE	General disorders	MedDRA (17.0)	Systematic Assessment	EG00053 affected356 at risk EG00116 affected85 at risk EG00252 affected353 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA (17.0)	Systematic Assessment	EG000195 affected356 at risk EG00159 affected85 at risk EG002168 affected353 at risk EG003
INJECTION SITE INDURATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG00052 affected356 at risk EG00113 affected85 at risk EG00262 affected353 at risk EG003
INJECTION SITE PAIN	General disorders	MedDRA (17.0)	Systematic Assessment	EG00077 affected356 at risk EG00118 affected85 at risk EG00289 affected353 at risk EG003
INJECTION SITE SWELLING	General disorders	MedDRA (17.0)	Systematic Assessment	EG00039 affected356 at risk EG0018 affected85 at risk EG00247 affected353 at risk EG003
PYREXIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG00015 affected356 at risk EG0013 affected85 at risk EG00227 affected353 at risk EG003
VACCINATION SITE ERYTHEMA	General disorders	MedDRA (17.0)	Systematic Assessment	EG00082 affected356 at risk EG00119 affected85 at risk EG00279 affected353 at risk EG003
VACCINATION SITE INDURATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG00026 affected356 at risk EG0015 affected85 at risk EG00222 affected353 at risk EG003
VACCINATION SITE SWELLING	General disorders	MedDRA (17.0)	Systematic Assessment	EG00013 affected356 at risk EG0015 affected85 at risk EG00219 affected353 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG00013 affected356 at risk EG0011 affected85 at risk EG00228 affected353 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG00019 affected356 at risk EG0016 affected85 at risk EG00228 affected353 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected356 at risk EG0015 affected85 at risk EG00212 affected353 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00033 affected356 at risk EG0019 affected85 at risk EG00233 affected353 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00045 affected356 at risk EG00119 affected85 at risk EG00241 affected353 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00053 affected356 at risk EG00121 affected85 at risk EG00254 affected353 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00021 affected356 at risk EG0017 affected85 at risk EG00224 affected353 at risk EG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA				Vaccine Group Ratios	0.46			2-Sided	95	0.37	0.58					Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667.

Title

Denominators

Categories

Day 8 (N= 363, 362)

Title	Measurements
	OG0000.23(0.21 to 0.25) OG0010.14(0.13 to 0.15)

Day 15 (N= 357, 361)

Title	Measurements
	OG00018(17 to 20) OG00112(10 to 13)

Day 91 (N= 358, 362)

Title	Measurements
	OG0002.32(2.09 to 2.56) OG0013.68(3.32 to 4.07)

Day 181 (N= 357, 360)

Title	Measurements
	OG0001.59(1.41 to 1.78) OG0011.44(1.28 to 1.62)

Day 366 (N= 356, 352)

Title	Measurements
	OG0001.59(1.41 to 1.79) OG0011.14(1.01 to 1.28)

Group IDs	Statistical Method	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	ANOVA	Vaccine Group Ratios	1.04	2-Sided	95	0.84	1.29	Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)
OG000 OG001	ANOVA	Vaccine Group Ratios	1.68	2-Sided	95	1.35	2.1	Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)
OG000 OG001	ANOVA	Vaccine Group Ratios	0.68	2-Sided	95	0.54	0.85	Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91).
OG000 OG001	ANOVA	Vaccine Group Ratios	1.22	2-Sided	95	0.94	1.59	Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)
OG000 OG001	ANOVA	Vaccine Group Ratios	1.67	2-Sided	95	1.27	2.19	Non-Inferiority or Equivalence	The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)

Title

Denominators

Categories

Day 8 (N= 363, 362)

Title	Measurements
	OG00018(15 to 23) OG00110(7 to 13)

Day 15 (N= 357, 361)

Title	Measurements
	OG000100(99 to 100) OG001100(98 to 100)

Day 91 (N= 358, 362)

Title	Measurements
	OG00096(94 to 98) OG00199(98 to 100)

Day 181 (N= 357, 360)

Title	Measurements
	OG00093(90 to 95) OG00193(90 to 96)

Day 366 (N= 356, 352)

Title	Measurements
	OG00090(86 to 93) OG00183(79 to 87)

Group IDs	Statistical Method	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Fisher Exact	Protection Rate Differences	9	2-Sided	95	3.8	13.9	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	0	2-Sided	95	-1	1.6	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	-3	2-Sided	95	-6	-1.4	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	-1	2-Sided	95	-4.5	3.2	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	6	2-Sided	95	1.3	11.5	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is > -0.05 (non-inferiority margin).

Title

Denominators

Categories

Day 8 (N= 66, 150)

Title	Measurements
	OG0000.21(0.17 to 0.26) OG0010.15(0.13 to 0.17)

Day 15 (N= 65, 146)

Title	Measurements
	OG00013(11 to 15) OG00115(13 to 17)

Day 50 (N= 65, 146)

Title	Measurements
	OG0001.97(1.6 to 2.43) OG0014.47(3.9 to 5.13)

Day 91 (N= 65, 149)

Title	Measurements
	OG0001.01(0.81 to 1.27) OG0012.28(1.96 to 2.65)

Day 181 (N= 65, 146)

Title	Measurements
	OG0000.88(0.67 to 1.14) OG0011.92(1.61 to 2.29)

Day 366 (N= 65, 145)

Title	Measurements
	OG0000.68(0.53 to 0.88) OG0011.42(1.19 to 1.69)

Group IDs	Statistical Method	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Fisher Exact	Protection Rate Differences	-11	2-Sided	95	-19.6	-1	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	0	2-Sided	95	-5.6	2.6	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	-15	2-Sided	95	-26	-7.1	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	-17	2-Sided	95	-29	-7.1	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is > -0.05 (non-inferiority margin).
OG000 OG001	Fisher Exact	Protection Rate Differences	-25	2-Sided	95	-37.8	-13.2	Non-Inferiority or Equivalence	The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is > -0.05 (non-inferiority margin).

Title

Denominators

Categories

Day 1 (N= 66, 151)

Title	Measurements
	OG0000(0 to 5) OG0010(0 to 2)

Day 8 (N= 66, 150)

Title	Measurements
	OG0008(3 to 17) OG00119(13 to 26)

Day 15 (N= 65, 146)

Title	Measurements
	OG000100(94 to 100) OG001100(98 to 100)

Day 50 (N= 65, 146)

Title	Measurements
	OG00095(87 to 99) OG001100(98 to 100)

Day 91 (N= 65, 149)

Title	Measurements
	OG00083(72 to 91) OG00198(94 to 100)

Day 181 (N= 65, 146)

Title	Measurements
	OG00077(65 to 86) OG00194(89 to 97)

Day 366 (N= 65, 145)

Title	Measurements
	OG00066(53 to 77) OG00191(85 to 95)

Title

Denominators

Categories

Day 1 (N=298, 290)

Title	Measurements
	OG0000.05(0.05 to 0.05) OG0010.05(0.05 to 0.05)

Day 8 (N= 297, 290)

Title	Measurements
	OG0000.23(0.21 to 0.25) OG0010.13(0.12 to 0.14)

Day 15 (N= 292, 289)

Title	Measurements
	OG00019(17 to 21) OG00112(11 to 13)

Day 50 (N= 292, 281)

Title	Measurements
	OG0005.04(4.56 to 5.57) OG00110(9.48 to 12)

Day 91 (N= 293, 290)

Title	Measurements
	OG0002.54(2.29 to 2.82) OG0013.8(3.42 to 4.21)

Day 181 (N= 292, 289)

Title	Measurements
	OG0001.73(1.53 to 1.95) OG0011.5(1.32 to 1.69)

Day 366 (N= 291, 283)

Title	Measurements
	OG0001.73(1.53 to 1.95) OG0011.2(1.06 to 1.36)

Title

Denominators

Categories

Day 8 (N= 297, 290)

Title	Measurements
	OG00021(16 to 26) OG00110(7 to 14)

Day 15 (N= 292, 289)

Title	Measurements
	OG000100(99 to 100) OG001100(99 to 100)

Day 50 (N= 292, 281)

Title	Measurements
	OG000100(99 to 100) OG001100(99 to 100)

Day 91 (N= 293, 290)

Title	Measurements
	OG00099(97 to 100) OG001100(98 to 100)

Day 181 (N= 292, 289)

Title	Measurements
	OG00096(93 to 98) OG00196(92 to 98)

Day 366 (N= 291, 283)

Title	Measurements
	OG00095(92 to 97) OG00187(82 to 90)

Title

Denominators

Categories

Injection site erythema(≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003NANo data as only adults to be enrolled to this group

Injection site erythema(≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site erythema(≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site erythema(≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site induration(≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site induration(≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site induration(≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site induration(≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Injection site swelling (≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site swelling (≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site swelling (≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site swelling (≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0028 OG003

Injection site erythema (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site erythema (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site erythema (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site erythema (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0028 OG003

Injection site induration (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site induration (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site induration (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Injection site induration (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site swelling (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site swelling (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Injection site swelling (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site swelling (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Injection site erythema (≥ 18 Y); Day 1

Title	Measurements
	OG0003 OG0016 OG0022 OG003

Injection site erythema (≥ 18 Y); Day 4

Title	Measurements
	OG00011 OG0014 OG0024 OG003

Injection site erythema (≥ 18 Y); Day 8

Title	Measurements
	OG00012 OG0011 OG0028 OG003

Injection site erythema (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG00227 OG003

Injection site induration (≥ 18 Y); Day 1

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Injection site induration (≥ 18 Y); Day 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Injection site induration (≥ 18 Y); Day 8

Title	Measurements
	OG0002 OG0010 OG0022 OG003

Injection site induration (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0024 OG003

Injection site swelling (≥ 18 Y); Day 1

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Injection site swelling (≥ 18 Y); Day 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Injection site swelling (≥ 18 Y); Day 8

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Injection site swelling (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0025 OG003

Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0026 OG003

Sleepiness (≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0027 OG003

Sleepiness (≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0007 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Sleepiness (≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0024 OG003

Sleepiness (≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Vomiting (≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Vomiting (≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Vomiting (≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Vomiting (≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0025 OG003

Diarrhea (≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Diarrhea (≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Diarrhea (≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Diarrhea (≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0024 OG003

Irritability.( ≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG0005 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Irritability.( ≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Irritability.( ≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0025 OG003

Irritability.( ≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0025 OG003

Chills(≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Chills(≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Chills(≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Chills(≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Nausea ( ≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Nausea ( ≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Nausea ( ≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Nausea ( ≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0005 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0024 OG003

Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Headache (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0008 OG001NANo data as only adults to be enrolled to this group OG0029 OG003

Headache (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0008 OG001NANo data as only adults to be enrolled to this group OG0028 OG003

Headache (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0006 OG001NANo data as only adults to be enrolled to this group OG0026 OG003

Headache (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Fatigue (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0008 OG001NANo data as only adults to be enrolled to this group OG0027 OG003

Fatigue (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0005 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Fatigue (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0026 OG003

Fatigue (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0026 OG003

Rash (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Rash (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Rash (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Rash (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Vomitting (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0025 OG003

Vomitting (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0002 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Vomitting (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Vomitting (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Diarrhea (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0004 OG001NANo data as only adults to be enrolled to this group OG0022 OG003

Diarrhea (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Diarrhea (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Diarrhea (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG0006 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0021 OG003

Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0020 OG003

Chills (≥ 18 Y); Day 1

Title	Measurements
	OG0008 OG0013 OG0025 OG003

Chills (≥ 18 Y); Day 4

Title	Measurements
	OG0001 OG0012 OG0026 OG003

Chills (≥ 18 Y); Day 8

Title	Measurements
	OG0005 OG0010 OG0024 OG003

Chills (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0020 OG003

Nausea,( ≥ 18 Y); Day 1

Title	Measurements
	OG0008 OG0013 OG0023 OG003

Nausea,( ≥ 18 Y); Day 4

Title	Measurements
	OG0004 OG0012 OG0022 OG003

Nausea,( ≥ 18 Y); Day 8

Title	Measurements
	OG0004 OG0010 OG0024 OG003

Nausea,( ≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0020 OG003

Generalized Myalgia (≥ 18 Y); Day 1

Title	Measurements
	OG00023 OG00112 OG00219 OG003

Generalized Myalgia (≥ 18 Y); Day 4

Title	Measurements
	OG00016 OG0017 OG00212 OG003

Generalized Myalgia (≥ 18 Y); Day 8

Title	Measurements
	OG00020 OG0015 OG00215 OG003

Generalized Myalgia (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0027 OG003

Generalized Arthralgia (≥ 18 Y); Day 1

Title	Measurements
	OG00018 OG0017 OG00213 OG003

Generalized Arthralgia (≥ 18 Y); Day 4

Title	Measurements
	OG0006 OG0015 OG00210 OG003

Generalized Arthralgia (≥ 18 Y); Day 8

Title	Measurements
	OG00015 OG0013 OG00215 OG003

Generalized Arthralgia (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0026 OG003

Headache (≥ 18 Y); Day 1

Title	Measurements
	OG00024 OG0016 OG00211 OG003

Headache (≥ 18 Y); Day 4

Title	Measurements
	OG00014 OG00110 OG00215 OG003

Headache (≥ 18 Y); Day 8

Title	Measurements
	OG00019 OG0018 OG00215 OG003

Headache (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG00212 OG003

Fatigue (≥ 18 Y); Day 1

Title	Measurements
	OG00028 OG00111 OG00219 OG003

Fatigue (≥ 18 Y); Day 4

Title	Measurements
	OG00021 OG0016 OG00217 OG003

Fatigue (≥ 18 Y); Day 8

Title	Measurements
	OG00019 OG0018 OG00215 OG003

Fatigue (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0029 OG003

Rash (≥ 18 Y); Day 1

Title	Measurements
	OG00010 OG0013 OG0024 OG003

Rash (≥ 18 Y); Day 4

Title	Measurements
	OG0004 OG0013 OG0028 OG003

Rash (≥ 18 Y); Day 8

Title	Measurements
	OG0006 OG0014 OG00211 OG003

Rash (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0022 OG003

Vomitting (≥ 18 Y); Day 1

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Vomitting (≥ 18 Y); Day 4

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Vomitting (≥ 18 Y); Day 8

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Vomitting (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0021 OG003

Diarrhea (≥ 18 Y); Day 1

Title	Measurements
	OG0005 OG0014 OG0022 OG003

Diarrhea (≥ 18 Y); Day 4

Title	Measurements
	OG0003 OG0012 OG0025 OG003

Diarrhea (≥ 18 Y); Day 8

Title	Measurements
	OG0005 OG0011 OG0024 OG003

Diarrhea (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0023 OG003

Loss Of Appetite (≥ 18 Y); Day 1

Title	Measurements
	OG0007 OG0010 OG0025 OG003

Loss Of Appetite (≥ 18 Y); Day 4

Title	Measurements
	OG0003 OG0012 OG0022 OG003

Loss Of Appetite (≥ 18 Y); Day 8

Title	Measurements
	OG0003 OG0013 OG0022 OG003

Loss Of Appetite (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG0021 OG003

Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1

Title	Measurements
	OG00015 OG001NANo data as only adults to be enrolled to this group OG0028 OG003

Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4

Title	Measurements
	OG0008 OG001NANo data as only adults to be enrolled to this group OG0029 OG003

Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8

Title	Measurements
	OG0007 OG001NANo data as only adults to be enrolled to this group OG0028 OG003

Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0029 OG003

Injection site pain (≥ 6 to ≤ 17 Y); Day 1

Title	Measurements
	OG00014 OG001NANo data as only adults to be enrolled to this group OG0027 OG003

Injection site pain (≥ 6 to ≤ 17 Y); Day 4

Title	Measurements
	OG0006 OG001NANo data as only adults to be enrolled to this group OG00210 OG003

Injection site pain (≥ 6 to ≤ 17 Y); Day 8

Title	Measurements
	OG0006 OG001NANo data as only adults to be enrolled to this group OG00211 OG003

Injection site pain (≥ 6 to ≤ 17 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANo data as only adults to be enrolled to this group OG0026 OG003

Injection site pain (≥ 18 Y); Day 1

Title	Measurements
	OG00012 OG0016 OG00216 OG003

Injection site pain (≥ 18 Y); Day 4

Title	Measurements
	OG0008 OG0018 OG00213 OG003

Injection site pain (≥ 18 Y); Day 8

Title	Measurements
	OG0008 OG0017 OG00221 OG003

Injection site pain (≥ 18 Y); Day 29

Title	Measurements
	OG000NANot assessed at Day 29 for this group OG001NANot assessed at Day 29 for this group OG00214 OG003

Title

Denominators

Categories

≥ 1 to ≤ 5 Y Any AEs;D1-366

Title	Measurements
	OG00045 OG001NANo data as only adults to be enrolled to this group OG00253 OG003NANo data as only adults to be enrolled to this group

≥ 1 to ≤ 5 Y SAE;D1-366

Title	Measurements
	OG0003 OG001NANo data as only adults to be enrolled to this group OG0024 OG003

≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥ 1 to ≤ 5 Y Deaths;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥ 6 to ≤ 17 Y Any AEs;D1-366

Title	Measurements
	OG00058 OG001NANo data as only adults to be enrolled to this group OG00271 OG003

≥ 6 to ≤ 17 Y SAE;D1-366

Title	Measurements
	OG0001 OG001NANo data as only adults to be enrolled to this group OG0023 OG003

≥6 to ≤ 17 Y At least possibly related SAEs;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥ 6 to ≤ 17 Y Deaths;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥6 to ≤17 Y Withdrawal from study due to AE;D1-366

Title	Measurements
	OG0000 OG001NANo data as only adults to be enrolled to this group OG0020 OG003

≥ 18 Y Any AEs;D1-366

Title	Measurements
	OG000157 OG00171 OG002156 OG003

≥ 18 Y SAE;D1-366

Title	Measurements
	OG0008 OG0013 OG0027 OG003

≥ 18 Y At least possibly related SAEs;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

≥ 18 Y Deaths;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

≥ 18 Y Withdrawal from study due to AE;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Overall population ≥ 1 Y Any AEs;D1-366

Title	Measurements
	OG000260 OG00171 OG002280 OG003

Overall population ≥ 1 Y SAE;D1-366

Title	Measurements
	OG00012 OG0013 OG00214 OG003

Overall ≥1Y Atleast possibly related SAEs;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Overall population ≥ 1 Y Deaths;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Overall population ≥1Y Withdrawal due to AE;D1-366

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Day 1 (N= 66, 72)

Title	Measurements
	OG0000.05(0.05 to 0.05) OG0010.05(0.05 to 0.05)

Day 8 (N= 66, 72)

Title	Measurements
	OG0000.21(0.17 to 0.26) OG0010.17(0.14 to 0.21)

Day 15 (N= 65, 72)

Title	Measurements
	OG00013(11 to 15) OG0018.37(6.96 to 10)

Day 50 (N= 65, 69)

Title	Measurements
	OG0001.97(1.6 to 2.43) OG0016.37(5.21 to 7.78)

Day 91 (N= 65, 72)

Title	Measurements
	OG0001.01(0.81 to 1.27) OG0012.25(1.81 to 2.79)

Day 181 (N= 65, 71)

Title	Measurements
	OG0000.88(0.67 to 1.14) OG0011.05(0.81 to 1.35)

Day 366 (N= 65, 69)

Title	Measurements
	OG0000.68(0.53 to 0.88) OG0010.59(0.46 to 0.76)

Title

Denominators

Categories

Day 1 (N= 66, 72)

Title	Measurements
	OG0000(0 to 5) OG0010(0 to 5)

Day 8 (N= 66, 72)

Title	Measurements
	OG0008(3 to 17) OG00110(4 to 19)

Day 15 (N= 65, 72)

Title	Measurements
	OG000100(94 to 100) OG00199(93 to 100)

Day 50 (N= 65, 69)

Title	Measurements
	OG00095(87 to 99) OG001100(95 to 100)

Day 91 (N= 65, 72)

Title	Measurements
	OG00083(72 to 91) OG00199(93 to 100)

Day 181 (N= 65, 71)

Title	Measurements
	OG00077(65 to 86) OG00185(74 to 92)

Day 366 (N= 65, 69)

Title	Measurements
	OG00066(53 to 77) OG00170(57 to 80)

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures