Antibody Persistence, and Safety and Tolerability of a Bo... | NCT01894919

ID	Type	Description	Link
2012-000657-30	EudraCT Number

Name	Class
GlaxoSmithKline	INDUSTRY

Antibody Persistence, and Safety and Tolerability of a Bo... | NCT01894919 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2H3H511_V	Experimental	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
2H3H511_NV	No Intervention	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
3H5_11_V	Experimental	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
3H5_11_NV	No Intervention	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
68_11_V	Experimental

Name	Type	Description	Arm Group Labels	Other Names
Bexsero® vaccine (1 dose at study month zero)	Biological		02_2_5_V 02_6_10_V 2H3H511_V 3H5_11_V 68_11_V

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains	The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).	24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains	The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.	At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains	The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.	24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.	The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For naïve subjects newly enrolled:

Healthy infants and children according to the following age groups:
1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age),
2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age).
3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age).
for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
in good health as determined by medical history, physical examination, clinical judgment of the investigator.

For Subjects who participated in the V72_28 study (Follow-on Subjects):

for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
in good health as determined by medical history, physical examination, clinical judgment of the investigator
who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1

Exclusion Criteria:

For naïve subjects newly enrolled:

History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
- Receipt of any chronic immunosuppressive therapy
- Receipt of any chronic immunostimulants
- Immune deficiency disorder, or known HIV infection
History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
Intent to participate in another clinical study during this study.
Family members and household members of study staff;
History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
Any significant chronic infection.
Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

For Subjects who participated in the V72_28 study (Follow-on Subjects):

Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Site 34, General Pediatric Practice Somorjai		Debrecen	Bajcsi Ut 32	4025	Hungary
Site 35, Praxis Dr Eva Kovacs

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29253560	Derived	Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0041 subjects FG0050 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0091 subjects FG0101 subjects FG0110 subjects FG0120 subjects
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Other-Unspecified		FG0001 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
BG001	2H3H511_NV	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
BG002	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
BG003	3H5_11_NV	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
BG004	68_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
BG005	68_11_NV	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
BG006	02_2_5_V	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
BG007	02_2_5_NV	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
BG008	02_6_10_V	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
BG009	02_6_10_NV	In the parent study V72_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
BG010	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
BG011	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
BG012	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
BG013	Total	Total of all reporting groups

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

Years

Title

Denominators

Categories

Title	Measurements
	BG0003.1± 0.2 BG0013± 0.18 BG0023.1± 0.23 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00044 BG00127 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

Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains

The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline.

The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).

Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

Posted

Number

95% Confidence Interval

Percentage of subjects

24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

ID	Title	Description
OG000	2H3H511	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG001	3H5_11	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG002	68_11	Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG003	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG004	02_2_5	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).
OG005	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
OG006	02_6_10	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).

Units	Counts
Participants	OG000140 OG001131 OG002119 OG003

Title	Denominators	Categories
H44/76	ParticipantsOG000140 ParticipantsOG001131 ParticipantsOG002119 ParticipantsOG003

Primary

Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains

The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.

Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

Posted

Number

95% Confidence Interval

Percentage of subjects

At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects

ID	Title	Description
OG000	2H3H511	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG001	3H5_11	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG002	68_11

Primary

The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains

The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.

Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Posted

Geometric Mean

97.5% Confidence Interval

Titers

24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

ID	Title	Description
OG000	2H3H511	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG001	3H5_11	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG002	68_11

Primary

The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.

The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At Day 1 in this study over one month after the completion of the vaccination course in the parent study

ID	Title	Description
OG000	2H3H511	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG001	3H5_11	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).
OG002

Primary

The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.

The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.

Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02_2_5 & 02_6_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02_2_5 & 02_6_10.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At Day 1 in this study over visit 1 in the vaccination course in the parent study

ID	Title	Description
OG000	02_2_5	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).
OG001	02_6_10	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).

Secondary

Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.

The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72_28 (excluding naïve groups).

Posted

Number

95% Confidence Interval

Percentage of subjects

At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.

The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Posted

Number

95% Confidence Interval

Percentage of subjects

At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.

The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Posted

Number

95% Confidence Interval

Percentage of subjects

One month after booster vaccination (day 31)/24-36 months (Visit 1)

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study

The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Posted

Number

95% Confidence Interval

Percentage of subjects

From post primary visit in the parent study to visit 2 in this extension study

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study.

The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02_2_5_V and 02_6_10_V

Posted

Number

95% Confidence Interval

Percentage of subjects

From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study

ID	Title	Description
OG000	02_2_5_V	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
OG001	02_6_10_V	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.

Secondary

The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.

The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.

Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Visit 1 and one month post booster vaccination (Day 31)

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.

The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.

Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At Day 31 versus Day 1

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.

The within-subjects GMR of hSBA antibody titers (one month post booster vaccination in this study versus 1 month post last vaccination visit (post-primary vaccination visit) in parent study V72_28.

Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination

The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.

Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Posted

Number

95% Confidence Interval

Percentage of subjects

At Baseline and One month post second vaccination (Day 61)

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG002	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Secondary

Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.

The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Baseline and One month post second vaccination (Day 61)

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG002	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Secondary

Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.

The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.

Posted

Number

95% Confidence Interval

Percentage of subjects

One month post second vaccination (Day 61)

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG002	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Secondary

The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.

The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Baseline and One month post second vaccination (Day 61)

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG002	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Secondary

The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.

The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At one month after receiving second vaccination (Day 61) versus baseline (Day 1)

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG002	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Secondary

Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.

The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study.

Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data

Posted

Number

Subjects

From day 1 (6 hr) through day 7 after vaccination

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
OG002	68_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine.

The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Posted

Number

Subjects

From day 1 (6 hr) through day 7 after vaccination

ID	Title	Description
OG000	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
OG001	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Units	Counts
Participants	OG000

Secondary

Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.

Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.

Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Posted

Number

Subjects

From day 1 (6 hr) through day 7 after vaccination

ID	Title	Description
OG000	02_6_10_V	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.

Units	Counts
Participants	OG000

Secondary

Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.

The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Posted

Number

Subjects

From day 1(6 hr) through day 7 after vaccination

ID	Title	Description
OG000	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.

The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.

Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

Posted

Number

Subjects

From day 1 through day 7 after any vaccination

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG002	68_11_V	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.

Secondary

Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.

The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.

Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

Posted

Number

Subjects

Throughout the entire study period (up to 2 months)

ID	Title	Description
OG000	2H3H511_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG001	3H5_11_V	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
OG002	68_11_V

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	2H3H511_V	In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	97	97	91	97
EG001	3H5_11_V	In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	89	89	84	89
EG002	68_11_V	In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	80	80	75	80
EG003	02_2_5_V	In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	32	32	31	32
EG004	02_6_10_V	In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	91	91	86	91
EG005	NAIVE 123	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	100	100	97	100
EG006	NAIVE_4A	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	55	55	55	55
EG007	NAIVE_4B	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	50	50	50	50

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected96 at risk EG0010 affected89 at risk EG0021 affected78 at risk EG0032 affected32 at risk EG0040 affected91 at risk EG0052 affected100 at risk EG0060 affected55 at risk EG0070 affected50 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Somnolence	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00028 affected96 at risk EG00123 affected89 at risk EG00226 affected78 at risk EG003
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Crying	General disorders	MedDRA 19.0	Systematic Assessment	EG00031 affected96 at risk EG00124 affected89 at risk EG00225 affected78 at risk EG003
Injection site erythema	General disorders	MedDRA 19.0	Systematic Assessment	EG00061 affected96 at risk EG00163 affected89 at risk EG00242 affected78 at risk EG003
Injection site induration	General disorders	MedDRA 19.0	Systematic Assessment	EG00048 affected96 at risk EG00148 affected89 at risk EG00233 affected78 at risk EG003
Injection site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG00084 affected96 at risk EG00180 affected89 at risk EG00271 affected78 at risk EG003
Injection site swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG00049 affected96 at risk EG00150 affected89 at risk EG00237 affected78 at risk EG003
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected96 at risk EG00118 affected89 at risk EG00212 affected78 at risk EG003
Eating disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00031 affected96 at risk EG00132 affected89 at risk EG00230 affected78 at risk EG003
Irritability	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00054 affected96 at risk EG00152 affected89 at risk EG00246 affected78 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected96 at risk EG0018 affected89 at risk EG0025 affected78 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected96 at risk EG0016 affected89 at risk EG0022 affected78 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected96 at risk EG0011 affected89 at risk EG0023 affected78 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected96 at risk EG0010 affected89 at risk EG0020 affected78 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected96 at risk EG0012 affected89 at risk EG0021 affected78 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected96 at risk EG0011 affected89 at risk EG0022 affected78 at risk EG003

Ancestor Terms

ID	Term
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D008589	Meningococcal Infections
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D008581	Meningitis
D000090862	Neuroinflammatory Diseases

5/99

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100
- ParticipantsOG00467
- ParticipantsOG00555
- ParticipantsOG006179
- ParticipantsOG00750

Title	Measurements
	OG00084(77.2 to 89.9) OG00188(80.9 to 92.9) OG00293(87.2 to 97.1) OG003

NZ98/254

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100
- ParticipantsOG00467
- ParticipantsOG00555
- ParticipantsOG006179
- ParticipantsOG00750

Title	Measurements
	OG00045(36.6 to 53.6) OG00138(29.8 to 47.1) OG00256(46.9 to 65.4) OG003

M10713

- ParticipantsOG000127
- ParticipantsOG001111
- ParticipantsOG002109
- ParticipantsOG00393
- ParticipantsOG00465
- ParticipantsOG00553
- ParticipantsOG006173
- ParticipantsOG00749

Title	Measurements
	OG00031(22.8 to 39.5) OG00136(27.1 to 45.7) OG00239(29.4 to 48.3) OG003

Title

Denominators

Categories

H44/76

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100
- ParticipantsOG00467
- ParticipantsOG00555
- ParticipantsOG006178
- ParticipantsOG00750

Title	Measurements
	OG00028(20.6 to 36.1) OG00126(18.7 to 34.3) OG00232(23.7 to 41.1) OG003

5/99

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100

NZ98/254

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100

M10713

- ParticipantsOG000127
- ParticipantsOG001111
- ParticipantsOG002109
- ParticipantsOG00393

Title

Denominators

Categories

H44/76

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100
- ParticipantsOG00467
- ParticipantsOG00555
- ParticipantsOG006178
- ParticipantsOG00750

Title	Measurements
	OG0004.17(3.4 to 5.13) OG0014.48(3.6 to 5.57) OG0025.62(4.48 to 7.04) OG003

5/99

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100

NZ98/254

- ParticipantsOG000140
- ParticipantsOG001131
- ParticipantsOG002119
- ParticipantsOG003100

M10713

- ParticipantsOG000127
- ParticipantsOG001111
- ParticipantsOG002109
- ParticipantsOG00393

Title

Denominators

Categories

H44/76

- ParticipantsOG000137
- ParticipantsOG001129
- ParticipantsOG002118
- ParticipantsOG00367
- ParticipantsOG004173

Title	Measurements
	OG0000.029(0.023 to 0.036) OG0010.022(0.017 to 0.028) OG0020.03(0.023 to 0.038) OG003

5/99

- ParticipantsOG000136
- ParticipantsOG001130
- ParticipantsOG002118
- ParticipantsOG00366

NZ98/254

- ParticipantsOG000136
- ParticipantsOG001129
- ParticipantsOG002116
- ParticipantsOG00368

M10713

- ParticipantsOG000105
- ParticipantsOG00184
- ParticipantsOG00278
- ParticipantsOG00361

Title

Denominators

Categories

H44/76

- ParticipantsOG00067
- ParticipantsOG001177

Title	Measurements
	OG0001.88(1.32 to 2.69) OG0012.94(2.33 to 3.71)

5/99

- ParticipantsOG00067
- ParticipantsOG001177

Title	Measurements
	OG00020(12 to 32) OG001

NZ98/254

- ParticipantsOG00067
- ParticipantsOG001177

Title	Measurements
	OG0002.48(1.76 to 3.49) OG001

M10713

- ParticipantsOG00056
- ParticipantsOG001163

Title	Measurements
	OG0000.89(0.49 to 1.61) OG001

Title

Denominators

Categories

H44/76 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00187
- ParticipantsOG00275
- ParticipantsOG00331
- ParticipantsOG00491
- ParticipantsOG00596
- ParticipantsOG00655
- ParticipantsOG00750

Title	Measurements
	OG00048(37.3 to 58.5) OG00151(40.1 to 62.1) OG00264(52.1 to 74.8) OG003

H44/76 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00187
- ParticipantsOG00275
- ParticipantsOG00332

5/99 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00331

5/99 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00332

NZ98/254 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

NZ98/254 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

M10713 (pre-vacc.)

- ParticipantsOG00078
- ParticipantsOG00168
- ParticipantsOG00265
- ParticipantsOG00329

M10713 (post-vacc.)

- ParticipantsOG00088
- ParticipantsOG00179
- ParticipantsOG00267
- ParticipantsOG00330

Title

Denominators

Categories

H44/76 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00331
- ParticipantsOG00491
- ParticipantsOG00596
- ParticipantsOG00655
- ParticipantsOG00750

Title	Measurements
	OG00026(17.5 to 36.3) OG00131(21.8 to 42.3) OG00233(22.9 to 45.2) OG003

H44/76 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

5/99 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00331

5/99 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00332

NZ98/254 (pre-vacc.)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

NZ98/54 (post-vacc.)

- ParticipantsOG00096
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

M10713 (pre-vacc.)

- ParticipantsOG00078
- ParticipantsOG00168
- ParticipantsOG00265
- ParticipantsOG00329

M10713 (post-vacc.)

- ParticipantsOG00088
- ParticipantsOG00179
- ParticipantsOG00267
- ParticipantsOG00330

Title

Denominators

Categories

H44/76 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00331
- ParticipantsOG00491
- ParticipantsOG00596
- ParticipantsOG00655
- ParticipantsOG00750

Title	Measurements
	OG00095(87.8 to 98.2) OG00195(88.5 to 98.7) OG00297(90.7 to 99.68) OG003

5/99 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00331

NZ98/254 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

M10713 (Day 31/PRE)

- ParticipantsOG00078
- ParticipantsOG00168
- ParticipantsOG00265
- ParticipantsOG00329

Title

Denominators

Categories

H44/76

- ParticipantsOG00094
- ParticipantsOG00184
- ParticipantsOG00275
- ParticipantsOG00332
- ParticipantsOG00488

Title	Measurements
	OG0005(1.7 to 12.0) OG0015(1.3 to 11.7) OG00213(6.6 to 23.2) OG003

5/99

- ParticipantsOG00093
- ParticipantsOG00186
- ParticipantsOG00276
- ParticipantsOG00332

NZ98/254

- ParticipantsOG00093
- ParticipantsOG00184
- ParticipantsOG00273
- ParticipantsOG00332

M10713

- ParticipantsOG00074
- ParticipantsOG00157
- ParticipantsOG00250
- ParticipantsOG00329

Title

Denominators

Categories

H44/76

- ParticipantsOG00032
- ParticipantsOG00191

Title	Measurements
	OG00097(83.8 to 99.92) OG00196(89.1 to 98.8)

5/99

- ParticipantsOG00032
- ParticipantsOG00190

Title	Measurements
	OG000100(89.1 to 100.0) OG001

NZ98/254

- ParticipantsOG00031
- ParticipantsOG00190

Title	Measurements
	OG00094(78.6 to 99.2) OG001

M10713

- ParticipantsOG00027
- ParticipantsOG00182

Title	Measurements
	OG00067(46.0 to 83.5) OG001

Title

Denominators

Categories

Title	Measurements
	OG0003.91(3.01 to 5.08) OG0014.84(3.66 to 6.41) OG0026.21(4.65 to 8.31) OG0033.14(2.08 to 4.75) OG0046.15(4.77 to 7.93) OG0052.82(2.26 to 3.5) OG0062.33(1.77 to 3.07) OG0071.93(1.39 to 2.68)

Title

Denominators

Categories

H44/76 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00331
- ParticipantsOG00491
- ParticipantsOG00596
- ParticipantsOG00655
- ParticipantsOG00750

Title	Measurements
	OG00041(30 to 55) OG00143(31 to 59) OG00246(33 to 65) OG003

5/99 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00187
- ParticipantsOG00276
- ParticipantsOG00331

NZ98/254 (Day 31/PRE)

- ParticipantsOG00092
- ParticipantsOG00186
- ParticipantsOG00275
- ParticipantsOG00332

M10713 (Day 31/PRE)

- ParticipantsOG00078
- ParticipantsOG00168
- ParticipantsOG00265
- ParticipantsOG00329

Title

Denominators

Categories

H44/76

- ParticipantsOG00094
- ParticipantsOG00184
- ParticipantsOG00275

Title	Measurements
	OG0001.06(0.82 to 1.38) OG0010.90(0.68 to 1.20) OG0021.37(1.02 to 1.84)

5/99

- ParticipantsOG00093
- ParticipantsOG00186
- ParticipantsOG00276

Title	Measurements
	OG000

NZ98/254

- ParticipantsOG00093
- ParticipantsOG00184
- ParticipantsOG00273

Title	Measurements
	OG000

M10713

- ParticipantsOG00074
- ParticipantsOG00157
- ParticipantsOG00250

Title	Measurements
	OG000

Title

Denominators

Categories

H44/76 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG00038(28.2 to 48.1) OG00126(15 to 39.7) OG00220(10.2 to 34.3)

H44/76 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

NZ98/254 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

NZ98/254 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

M10713 (baseline)

- ParticipantsOG00087
- ParticipantsOG00150
- ParticipantsOG00249

Title	Measurements
	OG000

M10713 (Day 61)

- ParticipantsOG00091
- ParticipantsOG00152
- ParticipantsOG00249

Title	Measurements
	OG000

Title

Denominators

Categories

H44/76 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG00017(10.4 to 26.3) OG00115(6.6 to 27.1) OG00210(3.4 to 22.2)

H44/76 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

NZ98/254 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

NZ98/254 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

M10713 (baseline)

- ParticipantsOG00087
- ParticipantsOG00150
- ParticipantsOG00249

Title	Measurements
	OG000

M10713 (Day 61)

- ParticipantsOG00091
- ParticipantsOG00152
- ParticipantsOG00249

Title	Measurements
	OG000

Title

Denominators

Categories

H44/76

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG00094(87.1 to 97.7) OG00189(77.4 to 95.8) OG00294(83.1 to 98.7)

5/99

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

NZ98/254

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

M10713

- ParticipantsOG00087
- ParticipantsOG00150
- ParticipantsOG00249

Title	Measurements
	OG000

Title

Denominators

Categories

H44/76 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG0002.3(1.75 to 3.01) OG0012.15(1.55 to 3) OG0021.56(1.11 to 2.2)

H44/76 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

5/99 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

NZ98/254 (baseline)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

NZ98/254 (Day 61)

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

M10713 (baseline)

- ParticipantsOG00087
- ParticipantsOG00150
- ParticipantsOG00249

Title	Measurements
	OG000

M10713 (Day 61)

- ParticipantsOG00091
- ParticipantsOG00152
- ParticipantsOG00249

Title	Measurements
	OG000

Title

Denominators

Categories

H44/76

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG00046(34 to 63) OG00134(24 to 50) OG00241(27 to 60)

5/99

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00249

Title	Measurements
	OG000

NZ98/254

- ParticipantsOG00098
- ParticipantsOG00154
- ParticipantsOG00248

Title	Measurements
	OG000

M10713

- ParticipantsOG00087
- ParticipantsOG00150
- ParticipantsOG00249

Title	Measurements
	OG000

Title

Denominators

Categories

Any local AEs

Title	Measurements
	OG00087 OG00181 OG00273 OG00331

Erythema

Title	Measurements
	OG00060 OG00163 OG00242 OG003

Induration

Title	Measurements
	OG00048 OG00148 OG00233 OG003

Swelling

Title	Measurements
	OG00049 OG00150 OG00237 OG003

Tenderness

Title	Measurements
	OG00084 OG00180 OG00271 OG003

Any systemic AEs

Title	Measurements
	OG00066 OG00163 OG00254 OG003

Change in eating habits

Title	Measurements
	OG00031 OG00132 OG00230 OG003

Diarrhea

Title	Measurements
	OG0004 OG0018 OG0025 OG003

Irritability

Title	Measurements
	OG00054 OG00152 OG00246 OG003

Persistent Crying

Title	Measurements
	OG00031 OG00124 OG00225 OG003

Rash

Title	Measurements
	OG00013 OG0011 OG0023 OG003

Sleepiness

Title	Measurements
	OG00028 OG00123 OG00226 OG003

Vomiting

Title	Measurements
	OG0005 OG0015 OG0022 OG003

Fever (>38.0° C)

Title	Measurements
	OG00017 OG00118 OG00211 OG003

Medically-Attended Fever

Title	Measurements
	OG0001 OG0010 OG0022 OG003

Prevention of Pain and/or Fever

Title	Measurements
	OG00023 OG00114 OG00215 OG003

Treatment of Pain and/or Fever

Title	Measurements
	OG00038 OG00139 OG00241 OG003

Title

Denominators

Categories

Any local AEs (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00088 OG00155

Erythema (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00054 OG001

Induration (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00038 OG001

Swelling (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00040 OG001

Tenderness (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00087 OG001

Any systemic AEs (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00064 OG001

Change in Eating Habits (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00031 OG001

Diarrhea (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG0004 OG001

Irritability (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00040 OG001

Persistent Crying (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00015 OG001

Rash (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG0005 OG001

Sleepiness (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00018 OG001

Vomiting (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG0007 OG001

Fever (>38.0° C) (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00015 OG001

Medically-Attended Fever (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG0001 OG001

Prevention of Pain/Fever (1st vacc.)

- ParticipantsOG000100
- ParticipantsOG00155

Title	Measurements
	OG00018 OG001

Treatment of Pain/Fever (1st vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00041 OG001

Any local AEs (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00079 OG001

Erythema (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00044 OG001

Induration (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00029 OG001

Swelling (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00032 OG001

Tenderness (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00077 OG001

Any systemic AEs (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00046 OG001

Change in Eating Habits (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00015 OG001

Diarrhea (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG0002 OG001

Irritability (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00025 OG001

Persistent Crying (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00013 OG001

Rash (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG0002 OG001

Sleepiness (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00012 OG001

Vomiting (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG0004 OG001

Fever (>38.0° C) (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00012 OG001

Medically-Attended Fever (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG0000 OG001

Prevention of Pain/Fever (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00021 OG001

Treatment of Pain/Fever (2nd vacc.)

- ParticipantsOG00099
- ParticipantsOG00155

Title	Measurements
	OG00030 OG001

Title

Denominators

Categories

Any local AEs

- ParticipantsOG00091

Title	Measurements
	OG00085

Erythema

- ParticipantsOG00091

Title	Measurements
	OG00057

Induration

- ParticipantsOG00091

Title	Measurements
	OG00044

Swelling

- ParticipantsOG00091

Title	Measurements
	OG00052

Pain

- ParticipantsOG00090

Title	Measurements
	OG00084

Any systemic AEs

- ParticipantsOG00091

Title	Measurements
	OG00057

Arthralgia

- ParticipantsOG00090

Title	Measurements
	OG00018

Chills

- ParticipantsOG00090

Title	Measurements
	OG00023

Headache

- ParticipantsOG00090

Title	Measurements
	OG00027

Malaise

- ParticipantsOG00090

Title	Measurements
	OG00035

Myalgia

- ParticipantsOG00090

Title	Measurements
	OG00024

Nausea

- ParticipantsOG00090

Title	Measurements
	OG00012

Rash

- ParticipantsOG00090

Title	Measurements
	OG00010

Fever (>38.0° C)

- ParticipantsOG00091

Title	Measurements
	OG00010

Medically-Attended Fever

- ParticipantsOG00091

Title	Measurements
	OG0000

Prevention of Pain and/or Fever

- ParticipantsOG00090

Title	Measurements
	OG00012

Treatment of Pain and/or Fever

- ParticipantsOG00091

Title	Measurements
	OG00047

Title

Denominators

Categories

Any local AEs (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00049

Erythema (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00031

Induration (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00019

Swelling (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00029

Pain (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG00047

Any systemic AEs (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00024

Arthralgia (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG0006

Chills (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG0004

Headache (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG00015

Malaise (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG0007

Myalgia (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG00012

Nausea (1st vacc.)

- ParticipantsOG00049

Title	Measurements
	OG0005

Rash (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0001

Fever (>38.0° C) (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0003

Medically-Attended Fever (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0000

Prevention of Pain and/or Fever (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0002

Treatment of Pain and/or Fever (1st vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00021

Any local AEs (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00043

Erythema (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00021

Induration (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00017

Swelling (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00021

Pain (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00041

Any systemic AEs (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00025

Arthralgia (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0003

Chills (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0005

Headache (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00010

Malaise (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00013

Myalgia (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0008

Nausea (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0004

Rash (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0003

Fever (>38.0° C) (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0001

Medically-Attended Fever (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0000

Prevention of Pain and/or Fever (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG0003

Treatment of Pain and/or Fever (2nd vacc.)

- ParticipantsOG00050

Title	Measurements
	OG00012

Title

Denominators

Categories

Any AEs

Title	Measurements
	OG00026 OG00119 OG00226 OG0039 OG00414 OG00543 OG00625 OG00712

Possibly or Probably Related AEs

Title	Measurements
	OG0009 OG0017 OG00210 OG003

AEs leading to Premature Withdrawal

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title	Measurements
	OG0003.48(2.78 to 4.36) OG0012.98(2.35 to 3.78) OG0024.86(3.8 to 6.22) OG0031.14(1.06 to 1.22) OG0042.81(2.07 to 3.82) OG0051.37(1.17 to 1.61) OG0064.57(3.74 to 5.59) OG0071.22(1.06 to 1.41)