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Clinical Trial Results:
The Long-Term Antibody Persistence Of Menacwy-TT Vaccine (PF-06866681) Versus Meningitec ® Or Mencevax ® ACWY In Healthy Adolescents And Adults And A Booster Dose Of Menacwy-TT Administered 10 Years Post-Primary Vaccination

Summary
EudraCT number	2013-001549-15
Trial protocol	FI
Global end of trial date	11 Jun 2018

Results information
Results version number	v1(current)
This version publication date	10 Mar 2019
First version publication date	10 Mar 2019
Other versions

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

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Trial information

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Sponsor protocol code

MenACWY-TT-100

ISRCTN number

US NCT number

NCT01962207

WHO universal trial number (UTN)

Other trial identifiers

Alias Study Number: C0921004

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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?

Analysis stage

Final

Date of interim/final analysis

11 Jun 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

11 Jun 2018

Was the trial ended prematurely?

Main objective of the trial

To evaluate long-term persistence of serum bactericidal (antibody) titers induced by meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine as compared to meningitec when administered to individuals 1 to less than (<)2 years of age in terms of percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), serogroup Y (MenY) titers greater than or equal to (>=)1:8, >=1:128, geometric mean titers (GMTs) as measured by a serum bactericidal assay using rabbit complement (rSBA) in those subjects that received MenACWY-TT, MenC rSBA titers >=1:8, >=1:128, GMTs in those subjects that received meningitec. To evaluate long-term persistence of serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to mencevax ACWY when administered to individuals 2-10 years of age in terms of percentage of subjects with MenA, MenC, MenW-135, and MenY titres >=1:8, >=1:128 and GMTs as measured by rSBA.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Oct 2013

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?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Finland: 243

Worldwide total number of subjects

243

EEA total number of subjects

243

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)

157

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

In this study, subjects from the study MENACWY-TT-027 [NCT00427908] were followed up for assessment of persistence of immune response and safety for 5 years followed by receiving booster vaccination (only eligible subjects who consented) and followed up for another 6 months.

Period 1 title

Persistence Phase (5 Years)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

MenACWY-TT Vaccine (Less Than [<] 2 Years)

Arm description

Persistence phase was followed up by booster phase. Persistence phase: Subjects with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027.

MenCCRM (Meningitec) Vaccine(<2 Years)

Arm description

Persistence phase was followed up by booster phase. Persistence phase: Subjects with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Arm type

Experimental

Investigational medicinal product name

MenCCRM Vaccine

Investigational medicinal product code

Other name

Meningitec

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027.

MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)

Arm description

Persistence phase was followed up by booster phase. Persistence phase: Subjects with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027.

MenPS (Mencevax ACWY) Vaccine (< 2 Years)

Arm description

Persistence phase was followed up by booster phase. Persistence phase: Subjects with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Arm type

Experimental

Investigational medicinal product name

MenPS Vaccine

Investigational medicinal product code

Other name

Mencevax

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027.

Number of subjects in period 1	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Started	76	23	115	29
Completed	47	10	71	17
Not completed	29	13	44	12
Consent withdrawn by subject	4	5	18	4
Eligibility criteria not fulfilled	-	-	3	1
Adverse event, non-fatal	-	-	1	-
Migrated/moved from study area	2	-	4	-
Lost to follow-up	2	1	5	2
Missed at least 1 persistence visit	21	7	13	5

Period 2 title

Booster Phase (6 Months)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

MenACWY-TT Vaccine: Less Than (<) 2 Years

Arm description

Persistence phase was followed up by booster phase. Persistence phase: Subjects with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Eligible subjects from persistence phase who provided consent were enrolled in booster phase and received a single 0.5 mL booster dose of MenACWY-TT in this study.

MenCCRM (Meningitec) Vaccine: Less Than 2 Years

Arm description

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Eligible subjects from persistence phase who provided consent were enrolled in booster phase and received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study.

MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years

Arm description

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Eligible subjects from persistence phase who provided consent were enrolled in booster phase and received a single 0.5 mL booster dose of MenACWY-TT in this study.

MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years

Arm description

Arm type

Experimental

Investigational medicinal product name

MenACWY-TT vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Subjects with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Eligible subjects from persistence phase who provided consent were enrolled in booster phase and received a single 0.5 mL booster dose of MenACWY-TT in this study.

Number of subjects in period 2	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Started	67	16	77	21
Completed	67	16	77	21

Baseline characteristics

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Reporting group title

MenACWY-TT Vaccine (Less Than [<] 2 Years)

Reporting group description

Reporting group title

MenCCRM (Meningitec) Vaccine(<2 Years)

Reporting group description

Reporting group title

MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)

Reporting group description

Reporting group title

MenPS (Mencevax ACWY) Vaccine (< 2 Years)

Reporting group description

Reporting group values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)	Total
Number of subjects	76	23	115	29	243
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	76	23	44	14	157
Adolescents (12-17 years)	0	0	70	15	85
Adults (18-64 years)	0	0	1	0	1
From 65-84 years	0	0	0	0	0
85 years and over	0	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	8.2 ( 0.7 )	8.2 ( 0.7 )	12.5 ( 2.6 )	12.1 ( 2.9 )	-
Sex: Female, Male
Units: Subjects
Female	40	12	56	14	122
Male	36	11	59	15	121
Race/Ethnicity, Customized
Units: Subjects
White - Arabic/North African heritage\|	0	0	1	0	1
White - Caucasian/European heritage\|	75	22	113	28	238
Other\|	1	1	1	1	4
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	76	23	115	29	243
Unknown or Not Reported	0	0	0	0	0

End points

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Reporting group title

MenACWY-TT Vaccine (Less Than [<] 2 Years)

Reporting group description

Reporting group title

MenCCRM (Meningitec) Vaccine(<2 Years)

Reporting group description

Reporting group title

MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)

Reporting group description

Reporting group title

MenPS (Mencevax ACWY) Vaccine (< 2 Years)

Reporting group description

Reporting group title

MenACWY-TT Vaccine: Less Than (<) 2 Years

Reporting group description

Reporting group title

MenCCRM (Meningitec) Vaccine: Less Than 2 Years

Reporting group description

Reporting group title

MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years

Reporting group description

Reporting group title

MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years

Reporting group description

Primary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination ^[1]

End point description

Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). All eligible subjects who received primary vaccination with MenACWY-TT, Meningitec, or Mencevax ACWY during study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. Here, “Overall Number of Subjects Analyzed” (N) signifies number of subjects evaluable for this measure.

End point type

Primary

End point timeframe

6 years after primary vaccination (Year 1 of study MENACWY-TT-100)

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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	54	16	98	24
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8	51.9 (37.8 to 65.7)	18.8 (4.0 to 45.6)	79.6 (70.3 to 87.1)	12.5 (2.7 to 32.4)
rSBA-MenC: >=1:8	77.8 (64.4 to 88.0)	75.0 (47.6 to 92.7)	82.7 (73.7 to 89.6)	79.2 (57.8 to 92.9)
rSBA-MenW-135: >=1:8	33.3 (21.1 to 47.5)	12.5 (1.6 to 38.3)	73.5 (63.6 to 81.9)	12.5 (2.7 to 32.4)
rSBA-MenY: >=1:8	38.9 (25.9 to 53.1)	37.5 (15.2 to 64.6)	71.4 (61.4 to 80.1)	20.8 (7.1 to 42.2)
rSBA-MenA: >=1:28	16.7 (7.9 to 29.3)	6.3 (0.2 to 30.2)	55.1 (44.7 to 65.2)	8.3 (1.0 to 27.0)
rSBA-MenC: >=1:28	70.4 (56.4 to 82.0)	56.3 (29.9 to 80.2)	68.4 (58.2 to 77.4)	62.5 (40.6 to 81.2)
rSBA-MenW-135: >=1:28	29.6 (18.0 to 43.6)	6.3 (0.2 to 30.2)	73.5 (63.6 to 81.9)	12.5 (2.7 to 32.4)
rSBA-MenY: >=1:28	33.3 (21.1 to 47.5)	31.3 (11.0 to 58.7)	65.3 (55.0 to 74.6)	20.8 (7.1 to 42.2)

No statistical analyses for this end point

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination ^[2]

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of subjects evaluable for this measure. “Number analyzed (n)”: subjects analyzed for specified serogroup titers cut off.

End point type

Primary

End point timeframe

7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

Notes
[2] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	60	21	104	27
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8 (n:60, 21, 104, 27)	58.3 (44.9 to 70.9)	9.5 (1.2 to 30.4)	74.0 (64.5 to 82.1)	18.5 (6.3 to 38.1)
rSBA-MenC: >=1:8 (n:60, 21, 101, 27)	78.3 (65.8 to 87.9)	71.4 (47.8 to 88.7)	84.2 (75.6 to 90.7)	81.5 (61.9 to 93.7)
rSBA-MenW-135: >=1:8 (n:60, 21, 102, 27)	26.7 (16.1 to 39.7)	9.5 (1.2 to 30.4)	73.5 (63.9 to 81.8)	11.1 (2.4 to 29.2)
rSBA-MenY: >=1:8 (n:60, 21, 102, 27)	35.0 (23.1 to 48.4)	28.6 (11.3 to 52.2)	75.5 (66.0 to 83.5)	14.8 (4.2 to 33.7)
rSBA-MenA: >=1:28 (n:60, 21, 104, 27)	21.7 (12.1 to 34.2)	9.5 (1.2 to 30.4)	44.2 (34.5 to 54.3)	11.1 (2.4 to 29.2)
rSBA-MenC: >=1:28 (n:60, 21, 101, 27)	61.7 (48.2 to 73.9)	52.4 (29.8 to 74.3)	61.4 (51.2 to 70.9)	66.7 (46.0 to 83.5)
rSBA-MenW-135: >=1:28 (n:60, 21, 102, 27)	23.3 (13.4 to 36.0)	9.5 (1.2 to 30.4)	69.6 (59.7 to 78.3)	7.4 (0.9 to 24.3)
rSBA-MenY: >=1:28 (n:60, 21, 102, 27)	33.3 (21.7 to 46.7)	28.6 (11.3 to 52.2)	69.6 (59.7 to 78.3)	14.8 (4.2 to 33.7)

No statistical analyses for this end point

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination ^[3]

End point description

End point type

Primary

End point timeframe

8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	65	22	100	25
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >=1:8	47.7 (35.1 to 60.5)	4.5 (0.1 to 22.8)	70.0 (60.0 to 78.8)	24.0 (9.4 to 45.1)
rSBA-MenC: >=1:8	78.5 (66.5 to 87.7)	77.3 (54.6 to 92.2)	85.0 (76.5 to 91.4)	88.0 (68.8 to 97.5)
rSBA-MenW-135: >=1:8	29.2 (18.6 to 41.8)	13.6 (2.9 to 34.9)	76.0 (66.4 to 84.0)	20.0 (6.8 to 40.7)
rSBA-MenY: >=1:8	40.0 (28.0 to 52.9)	40.9 (20.7 to 63.6)	79.0 (69.7 to 86.5)	24.0 (9.4 to 45.1)
rSBA-MenA: >=1:28	23.1 (13.5 to 35.2)	4.5 (0.1 to 22.8)	45.0 (35.0 to 55.3)	12.0 (2.5 to 31.2)
rSBA-MenC: >=1:28	64.6 (51.8 to 76.1)	50.0 (28.2 to 71.8)	61.0 (50.7 to 70.6)	64.0 (42.5 to 82.0)
rSBA-MenW-135: >=1:28	27.7 (17.3 to 40.2)	9.1 (1.1 to 29.2)	76.0 (66.4 to 84.0)	20.0 (6.8 to 40.7)
rSBA-MenY: >=1:28	38.5 (26.7 to 51.4)	40.9 (20.7 to 63.6)	73.0 (63.2 to 81.4)	20.0 (6.8 to 40.7)

No statistical analyses for this end point

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination ^[4]

End point description

End point type

Primary

End point timeframe

9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Notes
[4] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	21	93	25
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA >=1:8 (n:64, 21, 93, 25)	67.2 (54.3 to 78.4)	4.8 (0.1 to 23.8)	79.6 (69.9 to 87.2)	24.0 (9.4 to 45.1)
rSBA-MenC >=1:8 (n:64, 21, 93, 25)	81.3 (69.5 to 89.9)	85.7 (63.7 to 97.0)	86.0 (77.3 to 92.3)	84.0 (63.9 to 95.5)
rSBA-MenW-135 >=1:8 (n:64, 21, 92, 25)	32.8 (21.6 to 45.7)	9.5 (1.2 to 30.4)	76.1 (66.1 to 84.4)	16.0 (4.5 to 36.1)
rSBA-MenY >=1:8 (n:64, 21, 93, 25)	42.2 (29.9 to 55.2)	47.6 (25.7 to 70.2)	66.7 (56.1 to 76.1)	20.0 (6.8 to 40.7)
rSBA-MenA >=1:28 (n:64, 21, 93, 25)	31.3 (20.2 to 44.1)	4.8 (0.1 to 23.8)	57.0 (46.3 to 67.2)	16.0 (4.5 to 36.1)
rSBA-MenC >=1:28 (n:64, 21, 93, 25)	65.6 (52.7 to 77.1)	57.1 (34.0 to 78.2)	64.5 (53.9 to 74.2)	68.0 (46.5 to 85.1)
rSBA-MenW-135 >=1:28 (n:64, 21, 92, 25)	26.6 (16.3 to 39.1)	9.5 (1.2 to 30.4)	71.7 (61.4 to 80.6)	16.0 (4.5 to 36.1)
rSBA-MenY >=1:28 (n:64, 21, 93, 25)	34.4 (22.9 to 47.3)	38.1 (18.1 to 61.6)	58.1 (47.4 to 68.2)	16.0 (4.5 to 36.1)

No statistical analyses for this end point

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination ^[5]

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of subjects evaluable for this measure. “n”: subjects analyzed for this outcome measure for specified serogroup titers cut off.

End point type

Primary

End point timeframe

10 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Notes
[5] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	17	82	21
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA >=1:8 (n: 64, 17, 81, 21)	65.6 (52.7 to 77.1)	17.6 (3.8 to 43.4)	88.9 (80.0 to 94.8)	28.6 (11.3 to 52.2)
rSBA-MenC >=1:8 (n: 64, 17, 82, 21)	82.8 (71.3 to 91.1)	88.2 (63.6 to 98.5)	84.1 (74.4 to 91.3)	81.0 (58.1 to 94.6)
rSBA-MenW-135 >=1:8 (n: 64, 17, 82, 21)	31.3 (20.2 to 44.1)	0.0 (0.0 to 19.5)	67.1 (55.8 to 77.1)	23.8 (8.2 to 47.2)
rSBA-MenY >=1:8 (n: 64, 17, 82, 21)	43.8 (31.4 to 56.7)	35.3 (14.2 to 61.7)	65.9 (54.6 to 76.0)	23.8 (8.2 to 47.2)
rSBA-MenA >=1:28 (n: 64, 17, 81, 21)	26.6 (16.3 to 39.1)	5.9 (0.1 to 28.7)	49.4 (38.1 to 60.7)	14.3 (3.0 to 36.3)
rSBA-MenC >=1:28 (n: 64, 17, 82, 21)	64.1 (51.1 to 75.7)	58.8 (32.9 to 81.6)	65.9 (54.6 to 76.0)	66.7 (43.0 to 85.4)
rSBA-MenW-135 >=1:28 (n: 64, 17, 82, 21)	28.1 (17.6 to 40.8)	0.0 (0.0 to 19.5)	65.9 (54.6 to 76.0)	23.8 (8.2 to 47.2)
rSBA-MenY >=1:28 (n: 64, 17, 82, 21)	35.9 (24.3 to 48.9)	29.4 (10.3 to 56.0)	59.8 (48.3 to 70.4)	19.0 (5.4 to 41.9)

No statistical analyses for this end point

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination ^[6]

End point description

End point type

Primary

End point timeframe

6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)

Notes
[6] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	54	16	98	24
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA	16.0 (9.8 to 26.1)	5.9 (3.1 to 11.3)	107.3 (66.0 to 174.3)	5.8 (3.5 to 9.6)
rSBA-MenC	161.3 (84.7 to 307.1)	103.1 (31.9 to 333.3)	192.9 (121.0 to 307.5)	98.7 (42.2 to 230.7)
rSBA-MenW-135	18.0 (9.8 to 32.9)	6.2 (3.1 to 12.3)	265.2 (154.9 to 454.1)	7.6 (3.7 to 15.6)
rSBA-MenY	21.5 (11.5 to 40.1)	21.7 (5.9 to 79.0)	136.4 (82.6 to 225.3)	11.6 (4.7 to 28.7)

No statistical analyses for this end point

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination ^[7]

End point description

End point type

Primary

End point timeframe

7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

Notes
[7] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	60	21	104	27
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA (n: 60, 21, 104, 27)	20.4 (12.1 to 34.4)	6.1 (3.3 to 11.4)	65.3 (40.5 to 105.4)	7.4 (4.0 to 13.8)
rSBA-MenC (n: 60, 21, 101, 27)	104.0 (58.0 to 186.3)	54.3 (18.5 to 158.9)	139.0 (87.8 to 220.0)	101.6 (42.1 to 245.0)
rSBA-MenW-135 (n: 60, 21, 102, 27)	13.0 (7.6 to 22.3)	6.8 (3.0 to 15.3)	206.0 (120.9 to 350.9)	6.3 (3.7 to 10.9)
rSBA-MenY (n: 60, 21, 102, 27)	19.9 (11.0 to 36.1)	18.3 (5.8 to 57.6)	152.7 (96.1 to 242.6)	8.2 (4.1 to 16.5)

No statistical analyses for this end point

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination ^[8]

End point description

End point type

Primary

End point timeframe

8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

Notes
[8] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	65	22	100	25
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA	15.8 (9.8 to 25.6)	4.8 (3.3 to 7.2)	51.3 (31.5 to 83.4)	7.8 (4.2 to 14.3)
rSBA-MenC	110.2 (65.9 to 184.3)	64.0 (26.0 to 157.4)	140.1 (91.3 to 214.9)	121.1 (52.2 to 281.1)
rSBA-MenW-135	15.3 (9.0 to 26.3)	6.4 (3.3 to 12.4)	252.5 (154.3 to 413.2)	11.8 (4.7 to 29.8)
rSBA-MenY	26.1 (14.4 to 47.5)	33.0 (9.8 to 111.0)	181.0 (115.0 to 284.9)	10.9 (4.8 to 24.6)

No statistical analyses for this end point

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination ^[9]

End point description

End point type

Primary

End point timeframe

9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Notes
[9] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	21	93	25
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA (n: 64, 21, 93, 25)	28.4 (16.5 to 48.9)	5.2 (3.0 to 9.0)	118.8 (71.1 to 198.6)	10.9 (4.5 to 26.2)
rSBA-MenC (n: 64, 21, 93, 25)	166.0 (92.3 to 298.7)	92.0 (32.7 to 259.1)	176.4 (106.8 to 291.3)	164.3 (66.5 to 405.8)
rSBA-MenW-135 (n: 64, 21, 92, 25)	17.3 (9.7 to 30.8)	6.6 (3.2 to 13.6)	274.0 (155.8 to 481.7)	9.7 (4.0 to 23.3)
rSBA-MenY (n: 64, 21, 93, 25)	23.1 (13.0 to 41.2)	32.0 (10.6 to 96.3)	106.2 (61.5 to 183.4)	10.0 (4.4 to 22.9)

No statistical analyses for this end point

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination ^[10]

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of subjects evaluable for this measure. “n”: subjects analyzed for specified serogroup. Here, 99999 signifies data was not calculated due to CI was not estimable due to the lack of variability of of antibody titer (all subjects had titers below the cutoff value 1:8).

End point type

Primary

End point timeframe

10 years after primary vaccination (Year 5 of study MENACWY-TT-100)

Notes
[10] - 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: Only descriptive data was planned to be analyzed for this endpoint.

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	17	82	21
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA (n: 64, 17, 81, 21)	29.3 (16.8 to 51.3)	5.8 (3.2 to 10.6)	106.0 (63.7 to 176.4)	9.1 (4.0 to 20.7)
rSBA-MenC (n: 64, 17, 82, 21)	132.2 (74.5 to 234.6)	81.7 (29.2 to 229.2)	175.0 (104.7 to 292.4)	105.0 (37.2 to 296.4)
rSBA-MenW-135 (n: 64, 17, 82, 21)	16.7 (9.5 to 29.3)	4.0 (-99999 to 99999)	187.2 (101.0 to 347.1)	14.0 (4.8 to 41.2)
rSBA-MenY (n: 64, 17, 82, 21)	25.8 (14.0 to 47.3)	22.2 (5.8 to 84.2)	90.5 (51.5 to 159.2)	12.7 (4.2 to 38.1)

No statistical analyses for this end point

Secondary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

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End point title

Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

End point description

End point type

Secondary

End point timeframe

6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	22	100	27
Units: percentage of subjects
number (confidence interval 95%)
Year 1: hSBA-MenA >=1:4 (n:44, 14, 90, 21)	34.1 (20.5 to 49.9)	28.6 (8.4 to 58.1)	42.2 (31.9 to 53.1)	42.9 (21.8 to 66.0)
Year 2: hSBA-MenA >=1:4 (n:60, 21, 99, 26)	26.7 (16.1 to 39.7)	14.3 (3.0 to 36.3)	26.3 (17.9 to 36.1)	26.9 (11.6 to 47.8)
Year 3: hSBA-MenA >=1:4 (n:64, 22, 97, 25)	32.8 (21.6 to 45.7)	27.3 (10.7 to 50.2)	28.9 (20.1 to 39.0)	40.0 (21.1 to 61.3)
Year 4: hSBA-MenA >=1:4 (n:63, 20, 86, 23)	39.7 (27.6 to 52.8)	30.0 (11.9 to 54.3)	43.0 (32.4 to 54.2)	30.4 (13.2 to 52.9)
Year 5: hSBA-MenA >=1:4 (n:61, 16, 69, 21)	31.1 (19.9 to 44.3)	25.0 (7.3 to 52.4)	34.8 (23.7 to 47.2)	33.3 (14.6 to 57.0)
Year 1: hSBA-MenC >=1:4 (n:53, 16, 97, 24)	92.5 (81.8 to 97.9)	93.8 (69.8 to 99.8)	93.8 (87.0 to 97.7)	100.0 (85.8 to 100.0)
Year 2: hSBA-MenC >=1:4 (n:59, 20, 96, 26)	89.8 (79.2 to 96.2)	100.0 (83.2 to 100.0)	88.5 (80.4 to 94.1)	92.3 (74.9 to 99.1)
Year 3: hSBA-MenC >=1:4 (n:64, 22, 96, 25)	92.2 (82.7 to 97.4)	95.5 (77.2 to 99.9)	89.6 (81.7 to 94.9)	96.0 (79.6 to 99.9)
Year 4: hSBA-MenC >=1:4 (n:63, 20, 90, 24)	90.5 (80.4 to 96.4)	95.0 (75.1 to 99.9)	86.7 (77.9 to 92.9)	91.7 (73.0 to 99.0)
Year 5: hSBA-MenC >=1:4 (n:62, 16, 79, 21)	91.9 (82.2 to 97.3)	93.8 (69.8 to 99.8)	91.1 (82.6 to 96.4)	100.0 (83.9 to 100.0)
Year 1: hSBA-MenW-135>=1:4 (n:47, 15, 92, 23)	70.2 (55.1 to 82.7)	13.3 (1.7 to 40.5)	81.5 (72.1 to 88.9)	30.4 (13.2 to 52.9)
Year 2: hSBA-MenW-135>=1:4 (n:58, 20, 98, 27)	60.3 (46.6 to 73.0)	20.0 (5.7 to 43.7)	79.6 (70.3 to 87.1)	18.5 (6.3 to 38.1)
Year 3: hSBA-MenW-135>=1:4 (n:64, 21, 94, 25)	39.1 (27.1 to 52.1)	19.0 (5.4 to 41.9)	56.4 (45.8 to 66.6)	12.0 (2.5 to 31.2)
Year 4: hSBA-MenW-135>=1:4 (n:58, 16, 79, 21)	44.8 (31.7 to 58.5)	18.8 (4.0 to 45.6)	68.4 (56.9 to 78.4)	9.5 (1.2 to 30.4)
Year 5: hSBA-MenW-135>=1:4 (n:54, 14, 67, 19)	44.4 (30.9 to 58.6)	21.4 (4.7 to 50.8)	61.2 (48.5 to 72.9)	26.3 (9.1 to 51.2)
Year 1: hSBA-MenY>=1:4 (n:41, 14, 89, 24)	31.7 (18.1 to 48.1)	7.1 (0.2 to 33.9)	65.2 (54.3 to 75.0)	25.0 (9.8 to 46.7)
Year 2: hSBA-MenY>=1:4 (n:56, 21, 100, 27)	51.8 (38.0 to 65.3)	33.3 (14.6 to 57.0)	75.0 (65.3 to 83.1)	40.7 (22.4 to 61.2)
Year 3: hSBA-MenY>=1:4 (n:63, 21, 93, 23)	50.8 (37.9 to 63.6)	38.1 (18.1 to 61.6)	72.0 (61.8 to 80.9)	34.8 (16.4 to 57.3)
Year 4: hSBA-MenY>=1:4 (n:61, 19, 84, 22)	32.8 (21.3 to 46.0)	26.3 (9.1 to 51.2)	67.9 (56.8 to 77.6)	27.3 (10.7 to 50.2)
Year 5: hSBA-MenY>=1:4 (n:58, 15, 73, 18)	41.4 (28.6 to 55.1)	40.0 (16.3 to 67.7)	72.6 (60.9 to 82.4)	44.4 (21.5 to 69.2)
Year 1: hSBA-MenA>=1:8 (n:44, 14, 90, 21)	31.8 (18.6 to 47.6)	28.6 (8.4 to 58.1)	41.1 (30.8 to 52.0)	33.3 (14.6 to 57.0)
Year 2: hSBA-MenA>=1:8 (n:60, 21, 99, 26)	25.0 (14.7 to 37.9)	14.3 (3.0 to 36.3)	26.3 (17.9 to 36.1)	23.1 (9.0 to 43.6)
Year 3: hSBA-MenA>=1:8 (n:64, 22, 97, 25)	32.8 (21.6 to 45.7)	27.3 (10.7 to 50.2)	28.9 (20.1 to 39.0)	36.0 (18.0 to 57.5)
Year 4: hSBA-MenA>=1:8 (n:63, 20, 86, 23)	30.2 (19.2 to 43.0)	20.0 (5.7 to 43.7)	43.0 (32.4 to 54.2)	26.1 (10.2 to 48.4)
Year 5: hSBA-MenA>=1:8 (n:61, 16, 69, 21)	26.2 (15.8 to 39.1)	18.8 (4.0 to 45.6)	33.3 (22.4 to 45.7)	28.6 (11.3 to 52.2)
Year 1: hSBA-MenC>=1:8 (n:53, 16, 97, 24)	92.5 (81.8 to 97.9)	93.8 (69.8 to 99.8)	93.8 (87.0 to 97.7)	100.0 (85.8 to 100.0)
Year 2: hSBA-MenC>=1:8 (n:59, 20, 96, 26)	89.8 (79.2 to 96.2)	100.0 (83.2 to 100.0)	88.5 (80.4 to 94.1)	92.3 (74.9 to 99.1)
Year 3: hSBA-MenC>=1:8 (n:64, 22, 96, 25)	92.2 (82.7 to 97.4)	95.5 (77.2 to 99.9)	89.6 (81.7 to 94.9)	96.0 (79.6 to 99.9)
Year 4: hSBA-MenC>=1:8 (n:63, 20, 90, 24)	90.5 (80.4 to 96.4)	95.0 (75.1 to 99.9)	85.6 (76.6 to 92.1)	91.7 (73.0 to 99.0)
Year 5: hSBA-MenC>=1:8 (n:62, 16, 79, 21)	91.9 (82.2 to 97.3)	93.8 (69.8 to 99.8)	91.1 (82.6 to 96.4)	100.0 (83.9 to 100.0)
Year 1: hSBA-MenW-135 >=1:8 (n:47, 15, 92, 23)	70.2 (55.1 to 82.7)	13.3 (1.7 to 40.5)	81.5 (72.1 to 88.9)	30.4 (13.2 to 52.9)
Year 2: hSBA-MenW-135 >=1:8 (n:58, 20, 98, 27)	60.3 (46.6 to 73.0)	20.0 (5.7 to 43.7)	79.6 (70.3 to 87.1)	18.5 (6.3 to 38.1)
Year 3: hSBA-MenW-135 >=1:8 (n:64, 21, 94, 25)	39.1 (27.1 to 52.1)	19.0 (5.4 to 41.9)	56.4 (45.8 to 66.6)	12.0 (2.5 to 31.2)
Year 4: hSBA-MenW-135 >=1:8 (n:58, 16, 79, 21)	44.8 (31.7 to 58.5)	18.8 (4.0 to 45.6)	67.1 (55.6 to 77.3)	9.5 (1.2 to 30.4)
Year 5: hSBA-MenW-135 >=1:8 (n:54, 14, 67, 19)	44.4 (30.9 to 58.6)	21.4 (4.7 to 50.8)	61.2 (48.5 to 72.9)	26.3 (9.1 to 51.2)
Year 1: hSBA-MenY >=1:8 (n:41, 14, 89, 24)	31.7 (18.1 to 48.1)	7.1 (0.2 to 33.9)	65.2 (54.3 to 75.0)	25.0 (9.8 to 46.7)
Year 2: hSBA-MenY >=1:8 (n:56, 21, 100, 27)	51.8 (38.0 to 65.3)	33.3 (14.6 to 57.0)	75.0 (65.3 to 83.1)	40.7 (22.4 to 61.2)
Year 3: hSBA-MenY >=1:8 (n:63, 21, 93, 23)	50.8 (37.9 to 63.6)	38.1 (18.1 to 61.6)	72.0 (61.8 to 80.9)	34.8 (16.4 to 57.3)
Year 4: hSBA-MenY >=1:8 (n:61, 19, 84, 22)	32.8 (21.3 to 46.0)	26.3 (9.1 to 51.2)	67.9 (56.8 to 77.6)	27.3 (10.7 to 50.2)
Year 5: hSBA-MenY >=1:8 (n:58, 15, 73, 18)	41.4 (28.6 to 55.1)	40.0 (16.3 to 67.7)	72.6 (60.9 to 82.4)	44.4 (21.5 to 69.2)

No statistical analyses for this end point

Secondary: Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

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End point title

Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

End point description

End point type

Secondary

End point timeframe

6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	64	22	100	27
Units: titers
geometric mean (confidence interval 95%)
Year 1: hSBA-MenA(n:44, 14, 90, 21)	4.7 (3.2 to 7.1)	3.5 (2.1 to 5.8)	6.5 (4.8 to 8.8)	5.9 (3.0 to 11.7)
Year 2: hSBA-MenA(n:60, 21, 99, 26)	3.8 (2.9 to 5.2)	2.8 (1.8 to 4.2)	4.5 (3.4 to 6.0)	4.7 (2.4 to 9.0)
Year 3: hSBA-MenA(n:64, 22, 97, 25)	5.0 (3.5 to 7.1)	3.7 (2.2 to 6.1)	4.6 (3.4 to 6.0)	6.7 (3.2 to 14.0)
Year 4: hSBA-MenA(n:63, 20, 86, 23)	4.8 (3.5 to 6.6)	3.4 (2.2 to 5.2)	6.6 (4.8 to 9.0)	4.5 (2.4 to 8.8)
Year 5: hSBA-MenA(n:61, 16, 69, 21)	4.2 (3.1 to 5.9)	3.1 (2.0 to 4.8)	4.6 (3.4 to 6.2)	5.4 (2.5 to 11.7)
Year 1: hSBA-MenC(n:53, 16, 97, 24)	542.5 (284.8 to 1033.5)	230.0 (84.3 to 628.1)	427.2 (260.7 to 700.0)	234.8 (122.2 to 451.1)
Year 2: hSBA-MenC(n:59, 20, 96, 26)	368.1 (191.9 to 706.0)	223.6 (105.8 to 472.7)	342.7 (200.7 to 585.4)	169.2 (67.3 to 425.2)
Year 3: hSBA-MenC(n:64, 22, 96, 25)	378.2 (210.7 to 679.0)	203.4 (73.8 to 560.9)	365.5 (214.1 to 624.1)	273.8 (103.8 to 722.1)
Year 4: hSBA-MenC(n:63, 20, 90, 24)	319.0 (172.7 to 589.0)	217.2 (82.8 to 569.9)	190.4 (112.1 to 323.4)	125.7 (51.2 to 308.8)
Year 5: hSBA-MenC(n:62, 16, 79, 21)	362.2 (207.2 to 633.4)	112.4 (41.2 to 307.0)	199.3 (118.4 to 335.7)	119.1 (50.2 to 282.5)
Year 1: hSBA-MenW-135(n:47, 15, 92, 23)	31.8 (17.5 to 57.8)	3.3 (1.6 to 6.8)	62.5 (42.0 to 93.1)	7.0 (2.9 to 16.9)
Year 2: hSBA-MenW-135(n:58, 20, 98, 27)	19.5 (11.6 to 32.7)	4.9 (1.9 to 12.5)	50.5 (34.5 to 74.1)	4.0 (2.1 to 7.3)
Year 3: hSBA-MenW-135(n:64, 21, 94, 25)	8.0 (5.1 to 12.6)	4.1 (1.9 to 8.6)	20.4 (13.0 to 32.2)	3.3 (1.8 to 6.0)
Year 4: hSBA-MenW-135(n:58, 16, 79, 21)	8.5 (5.3 to 13.5)	3.7 (1.6 to 8.4)	23.1 (14.7 to 36.1)	2.8 (1.7 to 4.4)
Year 5: hSBA-MenW-135(n:54, 14, 67, 19)	7.6 (4.8 to 11.8)	3.8 (1.7 to 8.2)	17.4 (10.8 to 28.0)	4.2 (2.2 to 8.0)
Year 1: hSBA-MenY(n:41, 14, 89, 24)	7.9 (4.1 to 15.2)	3.1 (1.2 to 7.6)	40.3 (23.9 to 68.1)	7.3 (2.7 to 19.8)
Year 2: hSBA-MenY(n:56, 21, 100, 27)	15.8 (9.0 to 27.7)	6.9 (2.9 to 16.6)	54.4 (35.0 to 84.4)	10.5 (4.4 to 25.0)
Year 3: hSBA-MenY(n:63, 21, 93, 23)	11.6 (7.3 to 18.6)	8.7 (3.5 to 21.5)	43.7 (27.5 to 69.5)	8.8 (3.4 to 22.5)
Year 4: hSBA-MenY(n:61, 19, 84, 22)	7.3 (4.4 to 11.9)	5.8 (2.3 to 15.0)	35.5 (21.5 to 58.8)	6.2 (2.5 to 15.3)
Year 5: hSBA-MenY(n:58, 15, 73, 18)	8.6 (5.3 to 14.2)	8.5 (2.8 to 25.7)	36.8 (22.4 to 60.7)	13.9 (4.2 to 46.0)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100) and had available assay results for the 1 month post booster vaccination blood sample. “N”: number of subjects evaluable for this measure. “n”: subjects analyzed for specified serogroup titers cut off.

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	62	16	74	17
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA: >= 1:8 (n:62, 16, 74, 17)	98.4 (91.3 to 100.0)	100.0 (79.4 to 100.0)	95.9 (88.6 to 99.2)	100.0 (80.5 to 100.0)
rSBA-MenC: >= 1:8 (n:62, 16, 74, 17)	100.0 (94.2 to 100.0)	100.0 (79.4 to 100.0)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
rSBA-MenW-135: >= 1:8 (n:62, 15, 74, 17)	100.0 (94.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (95.1 to 100.0)	94.1 (71.3 to 99.9)
rSBA-MenY >= 1:8 (n:62, 16, 74, 17)	98.4 (91.3 to 100.0)	100.0 (79.4 to 100.0)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
rSBA-MenA: >= 1:28 (n:62, 16, 74, 17)	98.4 (91.3 to 100.0)	100.0 (79.4 to 100.0)	95.9 (88.6 to 99.2)	100.0 (80.5 to 100.0)
rSBA-MenC: >= 1:28 (n:62, 16, 74, 17)	100.0 (94.2 to 100.0)	100.0 (79.4 to 100.0)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
rSBA-MenW-135: >= 1:28 (n:62, 15, 74, 17)	100.0 (94.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (95.1 to 100.0)	94.1 (71.3 to 99.9)
rSBA-MenY >= 1:28 (n:62, 16, 74, 17)	98.4 (91.3 to 100.0)	100.0 (79.4 to 100.0)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)

No statistical analyses for this end point

Secondary: Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

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End point title

Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

End point description

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	62	16	74	17
Units: titers
geometric mean (confidence interval 95%)
rSBA-MenA (n:62, 16, 74, 17)	5122.3 (3725.6 to 7042.6)	4871.0 (2465.1 to 9624.9)	4626.4 (3040.6 to 7039.4)	6414.2 (3878.5 to 10607.8)
rSBA-MenC (n:62, 16, 74, 17)	7163.5 (5478.0 to 9367.7)	5792.6 (3630.6 to 9242.2)	4020.0 (3319.0 to 4869.1)	15101.0 (7099.3 to 32121.5)
rSBA-MenW-135 (n:62, 15, 74, 17)	25911.2 (19119.7 to 35115.2)	17970.4 (11666.4 to 27680.7)	27944.4 (22213.8 to 35153.3)	10462.5 (3253.5 to 33645.5)
rSBA-MenY (n:62, 16, 74, 17)	7660.5 (5262.9 to 11150.3)	6316.9 (3223.8 to 12377.5)	7529.7 (5827.5 to 9729.2)	6959.2 (3636.7 to 13317.1)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With rSBA Booster Response at 1 Month After Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With rSBA Booster Response at 1 Month After Booster Vaccination

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination. All eligible subjects who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100), had available assay results for 1 month post booster vaccination blood sample. “N”: number of subjects evaluable for this measure. n”: subjects analyzed for specified serogroup.

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	62	16	74	17
Units: percentage of subjects
number (confidence interval 95%)
rSBA-MenA (n=62, 16, 73, 17)	90.3 (80.1 to 96.4)	100.0 (79.4 to 100.0)	87.7 (77.9 to 94.2)	94.1 (71.3 to 99.9)
rSBA-MenC (n=62, 16, 74, 17)	82.3 (70.5 to 90.8)	93.8 (69.8 to 99.8)	75.7 (64.3 to 84.9)	94.1 (71.3 to 99.9)
rSBA-MenW-135 (n=62, 15, 74, 17)	100.0 (94.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (95.1 to 100.0)	88.2 (63.6 to 98.5)
rSBA-MenY (n=62, 16, 74, 17)	95.2 (86.5 to 99.0)	87.5 (61.7 to 98.4)	93.2 (84.9 to 97.8)	100.0 (80.5 to 100.0)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of subjects evaluable for this measure. “n”: subjects analyzed for specified serogroup titers cut off.

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	62	16	74	17
Units: percentage of subjects
number (confidence interval 95%)
hSBA-MenA: >=1:4 (n=62, 16, 73, 17)	100.0 (94.2 to 100.0)	87.5 (61.7 to 98.4)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
hSBA-MenC: >=1:4 (n=59, 15, 71, 17)	100.0 (93.9 to 100.0)	100.0 (78.2 to 100.0)	100.0 (94.9 to 100.0)	94.1 (71.3 to 99.9)
hSBA-MenW-135: >=1:4 (n=62, 13, 74, 15)	100.0 (94.2 to 100.0)	100.0 (75.3 to 100.0)	100.0 (95.1 to 100.0)	100.0 (78.2 to 100.0)
hSBA-MenY: >=1:4 (n=61, 15, 74, 17)	100.0 (94.1 to 100.0)	93.3 (68.1 to 99.8)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
hSBA-MenA: >=1:8 (n=62, 16, 73, 17)	100.0 (94.2 to 100.0)	87.5 (61.7 to 98.4)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)
hSBA-MenC: >=1:8 (n=59, 15, 71, 17)	100.0 (93.9 to 100.0)	100.0 (78.2 to 100.0)	100.0 (94.9 to 100.0)	94.1 (71.3 to 99.9)
hSBA-MenW-135: >=1:8 (n=62, 13, 74, 15)	100.0 (94.2 to 100.0)	100.0 (75.3 to 100.0)	100.0 (95.1 to 100.0)	100.0 (78.2 to 100.0)
hSBA-MenY: >=1:8 (n=61, 15, 74, 17)	100.0 (94.1 to 100.0)	93.3 (68.1 to 99.8)	100.0 (95.1 to 100.0)	100.0 (80.5 to 100.0)

No statistical analyses for this end point

Secondary: Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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End point title

Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

End point description

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	62	16	74	17
Units: titers
geometric mean (confidence interval 95%)
hSBA-MenA (n=62, 16, 73, 17)	1534.2 (1112.1 to 2116.6)	90.0 (35.7 to 227.1)	1213.0 (993.9 to 1480.5)	211.1 (130.9 to 340.3)
hSBA-MenC (n=59, 15, 71, 17)	33959.8 (23890.2 to 48273.5)	42559.2 (20106.2 to 90086.2)	15543.5 (11734.9 to 20588.3)	44794.4 (10111.6 to 198440.4)
hSBA-MenW-135 (n=62, 13, 74, 15)	11924.8 (8715.6 to 16315.7)	258.1 (155.7 to 427.8)	6965.2 (5274.3 to 9198.3)	199.6 (101.0 to 394.7)
hSBA-MenY (n=61, 15, 74, 17)	12154.3 (9660.9 to 15291.1)	407.8 (129.9 to 1280.3)	11127.4 (8909.2 to 13898.0)	453.9 (214.6 to 959.8)

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With hSBA Booster Response at 1 Month After Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With hSBA Booster Response at 1 Month After Booster Vaccination

End point description

Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination. All eligible subjects: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of subjects evaluable for this measure. “n”: subjects analyzed for specified serogroup.

End point type

Secondary

End point timeframe

1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	59	15	70	17
Units: percentage of subjects
number (confidence interval 95%)
hSBA-MenA (n:59, 15, 61, 17)	98.3 (90.9 to 100.0)	93.3 (68.1 to 99.8)	100.0 (94.1 to 100.0)	88.2 (63.6 to 98.5)
hSBA-MenC (n:57, 14, 70, 17)	86.0 (74.2 to 93.7)	92.9 (66.1 to 99.8)	85.7 (75.3 to 92.9)	94.1 (71.3 to 99.9)
hSBA-MenW-135 (n:52, 11, 59, 14)	100.0 (93.2 to 100.0)	90.9 (58.7 to 99.8)	96.6 (88.3 to 99.6)	100.0 (76.8 to 100.0)
hSBA-MenY (n:56, 14, 65, 14)	100.0 (93.6 to 100.0)	71.4 (41.9 to 91.6)	98.5 (91.7 to 100.0)	78.6 (49.2 to 95.3)

No statistical analyses for this end point

Secondary: Persistence Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event Related to Lack of Vaccine Efficacy

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End point title

Persistence Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event Related to Lack of Vaccine Efficacy

End point description

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to “lack of vaccine efficacy” were as judged by the investigator. All the subjects enrolled in the study.

End point type

Secondary

End point timeframe

Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	76	23	115	29
Units: percentage of subjects
number (not applicable)	0	0	0	0

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination

End point description

Solicited general events: fatigue, GI events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in mm as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Subjects may be represented in more than 1 category. Only categories with at least 1 subject reported. ‘Medical advice’ signifies medical advice received to resolve any event. ‘Related’=relationship to study vaccine assessed by investigator. Subjects who received a booster dose of study vaccine MenACWY-TT. n=subjects analyzed for specified category.

End point type

Secondary

End point timeframe

Up to 4 days post booster vaccination

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	67	16	77	21
Units: percentage of subjects
number (not applicable)
All pain(n: 67, 16, 74, 21)	59.7	56.3	59.5	61.9
Pain: Grade 1(n: 67, 16, 74, 21)	43.3	37.5	40.5	42.9
Pain: Grade 2(n: 67, 16, 74, 21)	16.4	18.8	16.2	19.0
Severe Pain: Grade 3(n: 67, 16, 74, 21)	0	0	0	0
All redness(n: 67, 16, 74, 21)	35.8	43.8	36.5	23.8
Redness: 0 to <=20 mm (n: 67, 16, 74, 21)	28.4	25.0	31.1	14.3
Redness: >20 to <=50 mm(n: 67, 16, 74, 21)	1.5	18.8	2.7	0.0
Redness: >50 mm(n: 67, 16, 74, 21)	6.0	0	2.7	9.5
All swelling(n: 67, 16, 77, 21)	17.9	6.3	23.0	14.3
Swelling: 0 to <=20 mm(n: 67, 16, 74, 21)	14.9	0	16.2	0.0
Swelling: >20 to <=50 mm(n: 67, 16, 74, 21)	1.5	6.3	1.4	4.8
Swelling: >50 mm(n: 67, 16, 74, 21)	1.5	0.0	5.4	9.5
All fatigue(n: 67, 16, 74, 21)	31.3	12.5	29.7	23.8
Fatigue: Grade 1(n: 67, 16, 74, 21)	20.9	12.5	16.2	14.3
Fatigue: Grade 2(n: 67, 16, 74, 21)	9.0	0.0	6.8	9.5
Fatigue: Grade 3(n: 67, 16, 74, 21)	1.5	0.0	6.8	0.0
Fatigue: Related fatigue(n: 67, 16, 74, 21)	31.3	12.5	29.7	23.8
Fatigue: Grade 3 Related(n: 67, 16, 74, 21)	1.5	0.0	6.8	0.0
All fever(n: 67, 16, 74, 21)	1.5	0.0	0.0	0.0
Fever: Grade 1(n: 67, 16, 74, 21)	1.5	0.0	0.0	0.0
Fever: Grade 2(n: 67, 16, 74, 21)	0.0	0.0	0.0	0.0
Fever: Grade 3(n: 67, 16, 74, 21)	0.0	0.0	0.0	0.0
Fever: Related(n: 67, 16, 74, 21)	1.5	0.0	0.0	0.0
Fever: Grade 3 related(n: 67, 16, 74, 21)	0.0	0.0	0.0	0.0
All gastrointestinal event(GI)(n: 67, 16, 74, 21)	9.0	0.0	17.6	14.3
GI: Grade 1(n: 67, 16, 74, 21)	7.5	0.0	13.5	4.8
GI: Grade 2(n: 67, 16, 74, 21)	1.5	0.0	2.7	9.5
GI: Grade 3(n: 67, 16, 74, 21)	0.0	0.0	1.4	0.0
GI: Related(n: 67, 16, 74, 21)	7.5	0.0	17.6	14.3
GI: Grade 3 related(n: 67, 16, 74, 21)	0.0	0.0	1.4	0.0
All headache(n: 67, 16, 74, 21)	20.9	31.3	27.0	23.8
Headache: Grade 1(n: 67, 16, 74, 21)	14.9	18.8	18.9	19.0
Headache: Grade 2(n: 67, 16, 74, 21)	6.0	12.5	6.8	4.8
Headache: Grade 3(n: 67, 16, 74, 21)	0.0	0.0	0.0	0.0
Headache: Related(n: 67, 16, 74, 21)	17.9	31.3	24.3	23.8
Headache: Grade 3 related(n: 67, 16, 74, 21)	0.0	0.0	1.4	0.0
Headache: Medical advice(n: 67, 16, 74, 21)	0.0	0.0	1.4	0.0

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination

End point description

An AE was any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Analysis population included all subjects who received a booster dose of study vaccine MenACWY-TT in the booster stage.

End point type

Secondary

End point timeframe

Up to 31 days post booster vaccination

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	67	16	77	21
Units: percentage of subjects
number (not applicable)	23.9	31.3	35.1	52.4

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination

End point description

An AE was any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Analysis population included all subjects who received a booster dose of study vaccine MenACWY-TT in the booster stage.

End point type

Secondary

End point timeframe

Up to 6 months post booster vaccination

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	67	16	77	21
Units: percentage of subjects
number (not applicable)	0.0	0.0	1.3	0.0

No statistical analyses for this end point

Secondary: Booster Phase: Percentage of Subjects With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

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End point title

Booster Phase: Percentage of Subjects With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

End point description

New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. Analysis population included all subjects who received a booster dose of study vaccine MenACWY-TT in the booster stage.

End point type

Secondary

End point timeframe

Up to 6 months post booster vaccination

End point values	MenACWY-TT Vaccine (Less Than [<] 2 Years)	MenCCRM (Meningitec) Vaccine(<2 Years)	MenACWY-TT Vaccine(Greater Than or Equal to [>=] 2 Years)	MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Number of subjects analysed	67	16	77	21
Units: percentage of subjects
number (not applicable)	0.0	0.0	1.3	4.8

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination

Adverse event reporting additional description

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject subject may have experienced both a serious and non-serious event.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Persistence Phase: MenACWY-TT Vaccine (<2 Years)

Reporting group description

Subjects with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination).

Reporting group title

Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)

Reporting group description

Subjects with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination).

Reporting group title

Persistence Phase: MenACWY-TT Vaccine (>=2 Years)

Reporting group description

Subjects with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination).

Reporting group title

Persistence Phase:MenPS (Mencevax ACWY) Vaccine (<2 Years)

Reporting group description

Subjects with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination).

Reporting group title

Booster Phase: MenACWY-TT Vaccine (<2 Years)

Reporting group description

Persistence phase: Subjects with <2 years of age, received a single 0.5mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.

Reporting group title

Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)

Reporting group description

Persistence phase: Subjects with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.

Reporting group title

Booster Phase: MenACWY-TT Vaccine (>= 2 Years)

Reporting group description

Persistence phase: Subjects with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.

Reporting group title

Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)

Reporting group description

Persistence phase: Subjects with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Subjects who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.

Serious adverse events	Persistence Phase: MenACWY-TT Vaccine (<2 Years)	Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)	Persistence Phase: MenACWY-TT Vaccine (>=2 Years)	Persistence Phase:MenPS (Mencevax ACWY) Vaccine (<2 Years)	Booster Phase: MenACWY-TT Vaccine (<2 Years)	Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)	Booster Phase: MenACWY-TT Vaccine (>= 2 Years)	Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Persistence Phase: MenACWY-TT Vaccine (<2 Years)	Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)	Persistence Phase: MenACWY-TT Vaccine (>=2 Years)	Persistence Phase:MenPS (Mencevax ACWY) Vaccine (<2 Years)	Booster Phase: MenACWY-TT Vaccine (<2 Years)	Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)	Booster Phase: MenACWY-TT Vaccine (>= 2 Years)	Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	53 / 67 (79.10%)	12 / 16 (75.00%)	65 / 77 (84.42%)	15 / 21 (71.43%)
Injury, poisoning and procedural complications
Foot fracture
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	1 / 16 (6.25%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Hand fracture
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Joint dislocation
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Headache 1
alternative assessment type: Systematic
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	14 / 67 (20.90%)	5 / 16 (31.25%)	20 / 77 (25.97%)	5 / 21 (23.81%)
occurrences all number	0	0	0	0	19	7	34	9
Headache
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	4 / 67 (5.97%)	1 / 16 (6.25%)	3 / 77 (3.90%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	5	1	4	0
Hypoaesthesia
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Migraine
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	2
Paraesthesia
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Blood and lymphatic system disorders
Lymph node pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Lymphadenitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	1
General disorders and administration site conditions
Axillary pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	1	0	0	1
Fatigue 1
alternative assessment type: Systematic
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	21 / 67 (31.34%)	2 / 16 (12.50%)	22 / 77 (28.57%)	5 / 21 (23.81%)
occurrences all number	0	0	0	0	31	4	48	8
Fatigue
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	1 / 16 (6.25%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	1	0	0
Injection site bruising
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	2 / 67 (2.99%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0
Injection site erythema (redness)
alternative assessment type: Systematic
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	24 / 67 (35.82%)	7 / 16 (43.75%)	27 / 77 (35.06%)	5 / 21 (23.81%)
occurrences all number	0	0	0	0	41	15	61	11
Injection site hypoaesthesia
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Injection site pain (pain at injection site)
alternative assessment type: Systematic
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	40 / 67 (59.70%)	9 / 16 (56.25%)	44 / 77 (57.14%)	13 / 21 (61.90%)
occurrences all number	0	0	0	0	72	18	80	25
Injection site pruritus
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	1 / 16 (6.25%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	1	1	0
Injection site swelling (swelling)
alternative assessment type: Systematic
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	12 / 67 (17.91%)	1 / 16 (6.25%)	17 / 77 (22.08%)	3 / 21 (14.29%)
occurrences all number	0	0	0	0	27	3	39	10
Pyrexia
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	2 / 67 (2.99%)	2 / 16 (12.50%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	2	2	1	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Coeliac disease
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	1
Gastrointestinal symptoms
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	6 / 67 (8.96%)	0 / 16 (0.00%)	13 / 77 (16.88%)	3 / 21 (14.29%)
occurrences all number	0	0	0	0	6	0	21	7
Vomiting
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	2 / 77 (2.60%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Cough
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	2 / 77 (2.60%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0
Throat irritation
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Sleep disorder
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Muscle tightness
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Musculoskeletal pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	1	1
Neck pain
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	1	0	0	1
Infections and infestations
Conjunctivitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	0 / 16 (0.00%)	0 / 77 (0.00%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Ear infection
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Gastroenteritis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	2 / 77 (2.60%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	2	1
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Infectious mononucleosis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Nasopharyngitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	1 / 16 (6.25%)	1 / 77 (1.30%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	1	1	1
Otitis media
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Respiratory tract infection
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	1 / 16 (6.25%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	1	0	1
Rhinitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	2 / 67 (2.99%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	2	0	0	1
Sinusitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Skin infection
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	0 / 77 (0.00%)	1 / 21 (4.76%)
occurrences all number	0	0	0	0	0	0	0	1
Tonsillitis
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	0 / 67 (0.00%)	0 / 16 (0.00%)	1 / 77 (1.30%)	0 / 21 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Upper respiratory tract infection
subjects affected / exposed	0 / 76 (0.00%)	0 / 23 (0.00%)	0 / 115 (0.00%)	0 / 29 (0.00%)	1 / 67 (1.49%)	1 / 16 (6.25%)	7 / 77 (9.09%)	2 / 21 (9.52%)
occurrences all number	0	0	0	0	1	1	7	2

More information

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Were there any global substantial amendments to the protocol? Yes

04 Feb 2016

1. Sponsor name updated throughout the protocol to Pfizer. 2. Blood sample volume increased to 10 mL for pre- and post-booster samples

25 Feb 2016

1. Blood sample volume increased to 10 mL for visit 4. 2. Initial pregnancy reporting and follow-up reports were updated to 24 hours and updated to indicate that paper SAE and EDP (exposure during pregnancy) reports were to be submitted for pregnancies. reports will be submitted for pregnancies.

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

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Clinical trials

Clinical Trial Results: The Long-Term Antibody Persistence Of Menacwy-TT Vaccine (PF-06866681) Versus Meningitec ® Or Mencevax ® ACWY In Healthy Adolescents And Adults And A Booster Dose Of Menacwy-TT Administered 10 Years Post-Primary Vaccination

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination

Primary: Persistence Phase: Percentage of Subjects With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

Primary: Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

Secondary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

Secondary: Persistence Phase: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

Secondary: Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

Secondary: Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

Secondary: Booster Phase: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

Secondary: Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With rSBA Booster Response at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With rSBA Booster Response at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With hSBA Booster Response at 1 Month After Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With hSBA Booster Response at 1 Month After Booster Vaccination

Secondary: Persistence Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event Related to Lack of Vaccine Efficacy

Secondary: Persistence Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event Related to Lack of Vaccine Efficacy

Secondary: Booster Phase: Percentage of Subjects With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

Secondary: Booster Phase: Percentage of Subjects With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
The Long-Term Antibody Persistence Of Menacwy-TT Vaccine (PF-06866681) Versus Meningitec ® Or Mencevax ® ACWY In Healthy Adolescents And Adults And A Booster Dose Of Menacwy-TT Administered 10 Years Post-Primary Vaccination