Clinical Trial Results:
A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with One Dose of Licensed Meningococcal ACWY Conjugate Vaccine (Menactra™) Administered to Healthy Children 2-10 Years of Age.

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2014-005161-72
Trial protocol	Outside EU/EEA
Global end of trial date	14 Oct 2009

Results information
Results version number	v2(current)
This version publication date	16 Jun 2016
First version publication date	30 Apr 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set re-QC of the study needed because of EudraCT system glitch and updates are required.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

V59P20

ISRCTN number

US NCT number

NCT00616421

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Vaccines and Diagnostics

Sponsor organisation address

4560 Horton Street, Emeryville, CA, United States, 94608-2916

Public contact

Posting Director, Novartis Vaccines and Diagnostics Inc., RegistryContactVaccinesUS@novartis.com

Scientific contact

Posting Director, Novartis Vaccines and Diagnostics Inc., RegistryContactVaccinesUS@novartis.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000032-PIP01-07

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

02 Feb 2010

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Oct 2009

Was the trial ended prematurely?

Main objective of the trial

To compare the immunogenicity of a single dose of MenACWY with the immunogenicity of a single dose of Menactra, defined as percentage of subjects with seroresponse directed against N. meningitides serogroups A, C, W-135 and Y, at 1 month after vaccination, when administered to healthy children 2 to 5 years of age. To compare the immunogenicity of a single dose of MenACWY with the immunogenicity of a single dose of Menactra, defined as percentage of subjects with seroresponse directed against N. meningitides serogroups A, C, W-135 and Y, at 1 month after vaccination, when administered to healthy children 6 to 10 years of age.

Protection of trial subjects

This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study is conducted. An independent, external Data Monitoring Committe (DMC) was established to monitor safety by performing scheduled analyses.

Background therapy

Evidence for comparator

Actual start date of recruitment

13 Mar 2008

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 2182

Country: Number of subjects enrolled

Canada: 725

Worldwide total number of subjects

2907

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

2906

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Participants were enrolled at 67 centres in the USA and Canada.

Screening details

All subjects enrolled were included in the trial.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

This was an observer-blind study except for those subjects in Group I who were administered two doses of MenACWY in an open-label fashion. For the observer-blind groups (II, III, IV and V), the subject, subject’s parent/legal guardian and those assessing subject safety, including the investigators, study nurses, and coordinators, were blind to vaccine administered.

Are arms mutually exclusive

MenACWY-CRM (2 Doses)

Arm description

2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 injections of the Novartis MenACWY-CRM vaccine administered by intramuscular (IM) injection.

MenACWY-CRM (1 Dose)_2 to 5 Years

Arm description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the Novartis MenACWY-CRM vaccine administered by intramuscular (IM) injection.

MenACWY-CRM (1 Dose)_6 to 10 Years

Arm description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the Novartis MenACWY-CRM vaccine administered by intramuscular (IM) injection.

Menactra_2 to 5 Years

Arm description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age

Arm type

Active comparator

Investigational medicinal product name

MenACWY polysaccharide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by intramuscular (IM) injection.

Menactra_6 to 10 Years

Arm description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age

Arm type

Active comparator

Investigational medicinal product name

MenACWY polysaccharide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by intramuscular (IM) injection.

MenACWY-CRM (1 Dose)_2 to 10 Years

Arm description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 10 years of age

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the Novartis MenACWY-CRM vaccine administered by intramuscular (IM) injection.

Menactra_2 to 10 Years

Arm description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 10 years of age.

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 injection of the Novartis MenACWY-CRM vaccine administered by intramuscular (IM) injection.

Number of subjects in period 1	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years
Started	359	696	582	696	574	1278	1270
Completed	333	669	571	672	557	1240	1229
Not completed	26	27	11	24	17	38	41
Consent withdrawn by subject	9	9	2	7	1	11	8
Lost to follow-up	12	18	8	16	14	26	30
Unable to Classify	1	-	-	-	-	-	-
Inappropriate Enrollment	3	-	-	1	-	-	1
Administrative reason	1	-	-	-	-	-	-
Protocol deviation	-	-	1	-	2	1	2

Baseline characteristics

Top of page

Reporting group title

MenACWY-CRM (2 Doses)

Reporting group description

2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age

Reporting group title

MenACWY-CRM (1 Dose)_2 to 5 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age

Reporting group title

MenACWY-CRM (1 Dose)_6 to 10 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age

Reporting group title

Menactra_2 to 5 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age

Reporting group title

Menactra_6 to 10 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age

Reporting group title

MenACWY-CRM (1 Dose)_2 to 10 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 10 years of age

Reporting group title

Menactra_2 to 10 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 10 years of age.

Reporting group values	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years	Total
Number of subjects	359	696	582	696	574	1278	1270
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	3.5 ± 1.1	3.5 ± 1.1	7.9 ± 1.4	3.5 ± 1.1	8.1 ± 1.4	5.5 ± 2.5	5.6 ± 2.6	-
Gender categorical
Units: Subjects
Female	171	342	280	331	249	622	580	1373
Male	188	354	302	365	325	656	690	1534

End points

Top of page

Reporting group title

MenACWY-CRM (2 Doses)

Reporting group description

2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age

Reporting group title

MenACWY-CRM (1 Dose)_2 to 5 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age

Reporting group title

MenACWY-CRM (1 Dose)_6 to 10 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age

Reporting group title

Menactra_2 to 5 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age

Reporting group title

Menactra_6 to 10 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age

Reporting group title

MenACWY-CRM (1 Dose)_2 to 10 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 10 years of age

Reporting group title

Menactra_2 to 10 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 10 years of age.

Subject analysis set title

Randomized Set

Subject analysis set type

Intention-to-treat

Subject analysis set description

All subjects who have signed an informed consent, undergone screening procedures, and have been randomized, i.e. all subjects who have data in panel DEMOG

Subject analysis set title

Modified Intention-to-treat (MITT) population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All subjects who actually receive a study vaccination and provide at least one evaluable serum sample both before and after vaccination.

Subject analysis set title

Safety

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects who have received at least one study dose and have post-baseline safety data will be included in the safety analysis

Subject analysis set title

Per Protocol population

Subject analysis set type

Per protocol

Subject analysis set description

All subjects in the MITT population who provide evaluable serum samples (titer results are available) both before and after vaccination, and have no major protocol deviation as defined prior to unblinding.

Primary: Percentages of Subjects With hSBA (human Serum Bactericidal Activity) Seroresponse, in Healthy Children 2 to 5 Years of Age

Top of page

End point title

Percentages of Subjects With hSBA (human Serum Bactericidal Activity) Seroresponse, in Healthy Children 2 to 5 Years of Age ^[1] ^[2]

End point description

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine (Menactra), in terms of the Percentages of subjects with seroresponse directed against N.meningitides serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a post vaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a post vaccination hSBA titer of at least 4 times the baseline. The analysis was performed on the per-protocol (PP) population.

End point type

Primary

End point timeframe

1 month post vaccination.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: statistical analyses not applicable for this endpoint.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 5 Years	Menactra_2 to 5 Years
Number of subjects analysed	607	615
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=606, 611)	72 (68 to 75)	77 (73 to 80)
Serogroup C (N=607, 615)	60 (56 to 64)	56 (52 to 60)
Serogroup W (N=594, 605)	72 (68 to 75)	58 (54 to 62)
Serogroup Y (N=593, 600)	66 (62 to 70)	45 (41 to 49)

No statistical analyses for this end point

Primary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age

Top of page

End point title

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age ^[3] ^[4]

End point description

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine (Menactra), in terms of the Percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. The analysis was performed on the per-protocol (PP) population.

End point type

Primary

End point timeframe

1 month postvaccination.

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: statistical analyses not applicable for this endpoint.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_6 to 10 Years
Number of subjects analysed	554	541
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=551, 541)	77 (73 to 80)	83 (79 to 86)
Serogroup C (N=554, 539)	63 (59 to 67)	57 (53 to 62)
Serogroup W (N=542, 533)	57 (53 to 61)	44 (40 to 49)
Serogroup Y (N=545, 539)	58 (54 to 62)	39 (35 to 44)

No statistical analyses for this end point

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.

Top of page

End point title

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. ^[5]

End point description

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine (Menactra), in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination.

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years
Number of subjects analysed	1161	1154
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=1157, 1152)	74 (71 to 76)	80 (77 to 82)
Serogroup C (N=1161, 1154)	61 (58 to 64)	57 (54 to 60)
Serogroup W (N=1136, 1138)	65 (62 to 67)	51 (48 to 54)
Serogroup Y (N=1138, 1139)	62 (60 to 65)	42 (40 to 45)

No statistical analyses for this end point

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age

Top of page

End point title

Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age ^[6]

End point description

End point type

Secondary

End point timeframe

1 month postvaccination.

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years
Number of subjects analysed	1161	1154
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=1157, 1152)	75 (72 to 77)	80 (78 to 83)
Serogroup C (N=1161, 1154)	72 (70 to 75)	68 (66 to 71)
Serogroup W (N=1136, 1138)	90 (88 to 92)	60 (57 to 63)
Serogroup Y (N=1138, 1139)	77 (75 to 80)	79 (77 to 81)

No statistical analyses for this end point

Secondary: Geometric Mean Titers hSBA in Healthy Children 2 to 10 Years of Age

Top of page

End point title

Geometric Mean Titers hSBA in Healthy Children 2 to 10 Years of Age ^[7]

End point description

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine (Menactra), in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination.

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years
Number of subjects analysed	1161	1154
Units: Titers
geometric mean (confidence interval 95%)
Serogroup A (N=1157, 1152)	30 (27 to 34)	29 (26 to 33)
Serogroup C (N=1161, 1154)	23 (21 to 27)	17 (15 to 20)
Serogroup W (N=1136, 1138)	49 (44 to 54)	26 (23 to 29)
Serogroup Y (N=1138, 1139)	29 (25 to 32)	12 (11 to 14)

No statistical analyses for this end point

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age

Top of page

End point title

Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age ^[8]

End point description

End point type

Secondary

End point timeframe

1 month postvaccination.

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years
Number of subjects analysed	607	554	615	541
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=606, 551, 611, 541)	72 (68 to 75)	77 (74 to 81)	78 (74 to 81)	83 (80 to 86)
Serogroup C (N=607, 554, 615, 539)	68 (64 to 72)	77 (73 to 80)	64 (60 to 68)	74 (70 to 77)
Serogroup W (N=594, 542, 605, 533)	90 (87 to 92)	91 (88 to 93)	75 (71 to 78)	84 (81 to 87)
Serogroup Y (N=593, 545, 600, 539)	76 (72 to 79)	79 (76 to 83)	57 (53 to 61)	63 (59 to 67)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age

Top of page

End point title

Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age ^[9]

End point description

The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine (Menactra), in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years
Number of subjects analysed	607	551	615	541
Units: Titers
geometric mean (confidence interval 95%)
Serogroup A (N=606, 551, 611, 541)	26 (22 to 30)	35 (29 to 42)	25 (21 to 29)	35 (29 to 41)
Serogroup C (N=607, 554, 615, 539)	18 (15 to 20)	36 (29 to 45)	13 (11 to 15)	27 (21 to 33)
Serogroup W (N=594, 542, 605, 533)	43 (38 to 50)	61 (52 to 72)	21 (19 to 25)	35 (30 to 42)
Serogroup Y (N=593, 545, 600, 539)	24 (20 to 28)	34 (28 to 41)	10 (8.68 to 12)	14 (12 to 17)

No statistical analyses for this end point

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)

Top of page

End point title

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) ^[10]

End point description

The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 1 month apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years
Number of subjects analysed	293	607
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=291, 606)	91 (87 to 94)	72 (68 to 75)
Serogroup C (N=293, 607)	98 (95 to 99)	60 (56 to 64)
Serogroup W (N=288, 594)	89 (85 to 92)	72 (68 to 75)
Serogroup Y (N=286, 593)	95 (91 to 97)	66 (62 to 70)

No statistical analyses for this end point

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Top of page

End point title

Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) ^[11]

End point description

The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM in terms of the percentages of subjects with hSBA ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years
Number of subjects analysed	293	607
Units: Percentages of Subjects
number (confidence interval 95%)
Serogroup A (N=291, 606)	91 (88 to 94)	72 (68 to 75)
Serogroup C (N=293, 607)	99 (97 to 100)	68 (64 to 72)
Serogroup W (N=288, 594)	99 (98 to 100)	90 (87 to 92)
Serogroup Y (N=286, 593)	98 (95 to 99)	76 (72 to 79)

No statistical analyses for this end point

Secondary: GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Top of page

End point title

GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) ^[12]

End point description

The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N.meningitidis serogroups A, C, W, and Y. The analysis was performed on the per-protocol (PP) population.

End point type

Secondary

End point timeframe

1 month postvaccination

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years
Number of subjects analysed	293	607
Units: Titers
geometric mean (confidence interval 95%)
Serogroup A (N=291, 606)	64 (51 to 81)	27 (23 to 32)
Serogroup C (N=293, 607)	144 (118 to 177)	18 (15 to 21)
Serogroup W (N=288, 594)	132 (111 to 157)	41 (36 to 47)
Serogroup Y (N=286, 593)	102 (82 to 126)	23 (20 to 27)

No statistical analyses for this end point

Secondary: Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age

Top of page

End point title

Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age ^[13]

End point description

Safety was assessed in terms of the percenatges of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group. The analysis was performed on the safety population.

End point type

Secondary

End point timeframe

Study days 1 to 7

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 5 Years	Menactra_2 to 5 Years
Number of subjects analysed	693	684
Units: Percentages of subjects
Injection site pain	226	241
Injection site erythema	186	170
Injection site induration	126	126
Change in Eating Habits (N=683, 671)	64	69
Sleepiness (N=692, 684)	109	126
Irritability (N=692, 684)	147	152
Vomiting (N=692, 684)	21	21
Diarrhoea (N=692, 684)	50	53
Arthralgia	24	24
Headache	33	39
Rash	30	34
Fever ( ≥ 38C ; N=692, 684)	15	17
Temperature ( ≥ 40.0C )	0	0
Stayed home (N=682, 670)	20	14
Analgesic/Antipyretic medication used	77	87

No statistical analyses for this end point

Secondary: Percentages of subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age

Top of page

End point title

Percentages of subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age ^[14]

End point description

Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group. The analysis was performed on the safety population.

End point type

Secondary

End point timeframe

Study days 1 to 7

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_6 to 10 Years
Number of subjects analysed	582	571
Units: Percentages of Subjects
Injection site pain	226	256
Injection site erythema	164	126
Injection site induration	97	73
Chills	30	26
Nausea	37	49
Malaise	82	62
Myalgia	61	59
Arthralgia	37	25
Headache	103	77
Rash	28	19
Fever ( ≥ 38C ; N=582, 570)	13	10
Temperature ( ≥ 40.0C; N=582, 570)	0	2
Stayed home (N=575,566)	17	13
Analgesic/Antipyretic medication used	52	56

No statistical analyses for this end point

Secondary: Percentages of subjects with unsolicited AEs occurring throughout the study in children aged 2 to 10 years

Top of page

End point title

Percentages of subjects with unsolicited AEs occurring throughout the study in children aged 2 to 10 years ^[15]

End point description

Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the study . The analysis was performed on the safety population.

End point type

Secondary

End point timeframe

Throughout the study

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM (1 Dose)_2 to 10 Years	Menactra_2 to 10 Years
Number of subjects analysed	1275	1255
Units: Percentages of Subjects
Any AEs	248	226
Possibly probably related AEs	60	62
SAEs	8	7
AEs leading to discontinuation	0	0
Possibly probably related SAEs	0	0
Death	0	0

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All adverse events and serious adverse events were collected throughout the entire study period.

Adverse event reporting additional description

If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

MenACWY-CRM (2 Doses)

Reporting group description

2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.

Reporting group title

MenACWY-CRM (1 Dose)_2 to 5 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.

Reporting group title

MenACWY-CRM (1 Dose)_6 to 10 Years

Reporting group description

1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.

Reporting group title

Menactra_2 to 5 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.

Reporting group title

Menactra_6 to 10 Years

Reporting group description

1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.

Serious adverse events	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 351 (0.57%)	5 / 693 (0.72%)	3 / 582 (0.52%)	5 / 684 (0.73%)	2 / 571 (0.35%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Injury, poisoning and procedural complications
ADRENAL HAEMATOMA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LACERATION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PULMONARY CONTUSION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RIB FRACTURE
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SKIN ABRASION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TRAUMATIC LIVER INJURY
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
LOSS OF CONSCIOUSNESS
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
PYREXIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
INGUINAL HERNIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
INTESTINAL OBSTRUCTION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 351 (0.28%)	0 / 693 (0.00%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MOUTH CYST
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	0 / 684 (0.00%)	1 / 571 (0.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	1 / 693 (0.14%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMOTHORAX
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
PSYCHIATRIC SYMPTOM
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	0 / 684 (0.00%)	1 / 571 (0.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
ARTHRITIS BACTERIAL
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BRONCHOPNEUMONIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 351 (0.28%)	0 / 693 (0.00%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CELLULITIS STAPHYLOCOCCAL
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PARVOVIRUS INFECTION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	1 / 351 (0.28%)	0 / 693 (0.00%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PERITONSILLAR ABSCESS
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	1 / 693 (0.14%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	2 / 693 (0.29%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SHIGELLA INFECTION
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	1 / 582 (0.17%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VIRAL INFECTION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	0 / 582 (0.00%)	1 / 684 (0.15%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	2 / 693 (0.29%)	0 / 582 (0.00%)	0 / 684 (0.00%)	0 / 571 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	MenACWY-CRM (2 Doses)	MenACWY-CRM (1 Dose)_2 to 5 Years	MenACWY-CRM (1 Dose)_6 to 10 Years	Menactra_2 to 5 Years	Menactra_6 to 10 Years
Total subjects affected by non serious adverse events
subjects affected / exposed	253 / 351 (72.08%)	424 / 693 (61.18%)	340 / 582 (58.42%)	419 / 684 (61.26%)	342 / 571 (59.89%)
Nervous system disorders
HEADACHE
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	27 / 351 (7.69%)	37 / 693 (5.34%)	105 / 582 (18.04%)	39 / 684 (5.70%)	79 / 571 (13.84%)
occurrences all number	35	39	136	47	105
SOMNOLENCE
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	81 / 351 (23.08%)	109 / 693 (15.73%)	0 / 582 (0.00%)	126 / 684 (18.42%)	0 / 571 (0.00%)
occurrences all number	118	122	0	145	0
General disorders and administration site conditions
CHILLS
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	30 / 582 (5.15%)	0 / 684 (0.00%)	26 / 571 (4.55%)
occurrences all number	0	0	33	0	26
INJECTION SITE ERYTHEMA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	131 / 351 (37.32%)	186 / 693 (26.84%)	164 / 582 (28.18%)	170 / 684 (24.85%)	126 / 571 (22.07%)
occurrences all number	198	199	170	177	132
INJECTION SITE INDURATION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	82 / 351 (23.36%)	126 / 693 (18.18%)	97 / 582 (16.67%)	126 / 684 (18.42%)	73 / 571 (12.78%)
occurrences all number	112	134	99	130	79
INJECTION SITE PAIN
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	151 / 351 (43.02%)	226 / 693 (32.61%)	226 / 582 (38.83%)	241 / 684 (35.23%)	256 / 571 (44.83%)
occurrences all number	211	238	242	251	264
MALAISE
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	82 / 582 (14.09%)	0 / 684 (0.00%)	62 / 571 (10.86%)
occurrences all number	0	0	88	0	71
PYREXIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	20 / 351 (5.70%)	25 / 693 (3.61%)	15 / 582 (2.58%)	20 / 684 (2.92%)	13 / 571 (2.28%)
occurrences all number	23	28	18	22	15
Gastrointestinal disorders
DIARRHOEA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	35 / 351 (9.97%)	52 / 693 (7.50%)	4 / 582 (0.69%)	55 / 684 (8.04%)	2 / 571 (0.35%)
occurrences all number	47	66	4	67	2
NAUSEA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	3 / 351 (0.85%)	2 / 693 (0.29%)	50 / 582 (8.59%)	0 / 684 (0.00%)	37 / 571 (6.48%)
occurrences all number	3	2	57	0	39
VOMITING
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	19 / 351 (5.41%)	25 / 693 (3.61%)	2 / 582 (0.34%)	22 / 684 (3.22%)	5 / 571 (0.88%)
occurrences all number	23	28	2	25	5
Skin and subcutaneous tissue disorders
RASH
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	31 / 351 (8.83%)	33 / 693 (4.76%)	28 / 582 (4.81%)	35 / 684 (5.12%)	21 / 571 (3.68%)
occurrences all number	34	36	29	38	26
Psychiatric disorders
EATING DISORDER
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	56 / 351 (15.95%)	64 / 693 (9.24%)	0 / 582 (0.00%)	69 / 684 (10.09%)	0 / 571 (0.00%)
occurrences all number	71	66	0	77	0
IRRITABILITY
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	98 / 351 (27.92%)	147 / 693 (21.21%)	0 / 582 (0.00%)	152 / 684 (22.22%)	0 / 571 (0.00%)
occurrences all number	156	172	0	176	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	20 / 351 (5.70%)	25 / 693 (3.61%)	38 / 582 (6.53%)	24 / 684 (3.51%)	25 / 571 (4.38%)
occurrences all number	21	27	41	27	29
MYALGIA
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	0 / 351 (0.00%)	0 / 693 (0.00%)	62 / 582 (10.65%)	0 / 684 (0.00%)	59 / 571 (10.33%)
occurrences all number	0	0	66	0	62
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	20 / 351 (5.70%)	13 / 693 (1.88%)	4 / 582 (0.69%)	9 / 684 (1.32%)	1 / 571 (0.18%)
occurrences all number	22	13	4	10	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

28 Jan 2008

Change in the primary objective: At the request of FDA the primary objective is changed as measure of seroresponse within each age group rather than in the total group of children aged 2-10 Addition of Data monitoring Committee

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/20943209

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentages of Subjects With hSBA (human Serum Bactericidal Activity) Seroresponse, in Healthy Children 2 to 5 Years of Age

Primary: Percentages of Subjects With hSBA (human Serum Bactericidal Activity) Seroresponse, in Healthy Children 2 to 5 Years of Age

Primary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age

Primary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age

Secondary: Geometric Mean Titers hSBA in Healthy Children 2 to 10 Years of Age

Secondary: Geometric Mean Titers hSBA in Healthy Children 2 to 10 Years of Age

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age

Secondary: Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age

Secondary: Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)

Secondary: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Secondary: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Secondary: GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Secondary: GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

Secondary: Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age

Secondary: Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age

Secondary: Percentages of subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age

Secondary: Percentages of subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age

Secondary: Percentages of subjects with unsolicited AEs occurring throughout the study in children aged 2 to 10 years

Secondary: Percentages of subjects with unsolicited AEs occurring throughout the study in children aged 2 to 10 years

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information