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CompletedNCT00616421Updated Feb 15, 2016Results posted

Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

A Phase 3 interventional study of MenACWY-CRM and MenACWY-CRM in Meningococcal Infections, sponsored by Novartis Vaccines. Completed at 68 sites in 2 countries. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-15.

Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,907
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study summary

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

02

Conditions studied

  • Meningococcal Infections

Keywords

  • vaccine
  • children
  • healthy
  • meningitis
  • meningococcal
  • prevention of meningococcal disease serogroups ACWY
  • Menveo
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 2,907 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
  • who are available for all visits and telephone calls scheduled for the study
  • who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion criteria

Exclusion Criteria:

  • whose parent or legal guardian is unwilling or unable to give written informed consent
  • who had a previous or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • who have received any investigational agents or vaccines within 90 days prior to enrollment
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
  • who have a history of anaphylaxis, serious vaccine reactions
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
  • who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
  • who have Down's syndrome or other known cytogenic disorders
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,907 participants (actual)

Study arms

  • Experimental
    MenACWY-CRM (1 dose)

    1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.

    Biological: MenACWY-CRM

  • Active comparator
    Licensed polysaccharide vaccine

    1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1

    Biological: Licensed meningococcal ACWY vaccine

  • Experimental
    MenACWY-CRM (2 doses)

    2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.

    Biological: MenACWY-CRM

Interventions

  • BiologicalMenACWY-CRM

    1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly

    Also known as: Menveo

  • BiologicalMenACWY-CRM

    2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age

    Also known as: Menveo

  • BiologicalLicensed meningococcal ACWY vaccine

    1 injection of the licensed meningococcal ACWY was administered intramuscularly

    Also known as: Menactra

06

What researchers measure

Primary outcomes

  1. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

    Time frame: 1 month postvaccination

  2. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages 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.

    Time frame: 1 month postvaccination

Secondary outcomes

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

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

    Time frame: 1 month postvaccination

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

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

    Time frame: 1 month postvaccination

  3. Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

    Time frame: 1 month postvaccination

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

    The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

    Time frame: 1 month postvaccination

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

    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, 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.

    Time frame: 1 month postvaccination

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

    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, 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.

    Time frame: 1 month postvaccination

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

    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, 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.

    Time frame: 1 month postvaccination

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

    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-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.

    Time frame: 1 month postvaccination

  9. Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.

    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, after 1 dose treatment.

    Time frame: Study days 1 to 7

  10. Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.

    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 after 1 dose treatment.

    Time frame: Study days 1 to 7

  11. Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.

    Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.

    Time frame: day 1 to study termination (day 240)

07

Results

Posted Jun 9, 2011

Participant flow

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

Participant flow — Overall Study
MilestoneMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
Started35912781270
Completed33312401229
Not completed263841
Withdrew: Withdrawal by subject9118
Withdrew: Lost to follow-up122630
Withdrew: Inappropriate enrollment301
Withdrew: Administrative reason100
Withdrew: Protocol violation012
Withdrew: Unable to classify100

Outcome measures

PrimaryPercentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Percentages of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
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)
SecondaryPercentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percenatage of subjects
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Percenatage of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
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)
PrimaryPercentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Percentages of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
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)
SecondaryPercentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percentage of subjects
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Percentage of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
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)
SecondaryGeometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, 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.

Time frame:
1 month postvaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
TitersMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine
Serogroup A (N=1157, 1152)30 (27 to 31)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)
SecondaryPercentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.

The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.

Time frame:
1 month postvaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Percentages of subjectsMenACWY-CRM (2 to 5 Yoa)Licensed Polysaccharide Vaccine (2 to 5 Yoa)MenACWY-CRM (6 to 10 Yoa)Licensed Polysaccharide Vaccine (6 to 10 Yoa)
Serogroup A (N=606, 611, 551, 541)72 (68 to 75)78 (74 to 81)77 (74 to 81)83 (80 to 86)
Serogroup C (N=607, 615, 554, 539)68 (64 to 72)64 (60 to 68)77 (73 to 89)74 (70 to 77)
Serogroup W (N=594, 605, 542, 533)90 (87 to 92)75 (71 to 78)91 (88 to 93)84 (81 to 87)
Serogroup Y (N=593, 600, 545, 539)76 (72 to 79)57 (53 to 61)79 (76 to 83)63 (59 to 67)
SecondaryGeometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.

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, 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.

Time frame:
1 month postvaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
TitersMenACWY-CRM (2 to 5 Yoa)Licensed Polysaccharide Vaccine (2 to 5 Yoa)MenACWY-CRM (6 to 10 Yoa)Licensed Polysaccharide Vaccine (6 to 10 Yoa)
Serogroup A (N=606, 611, 551, 541)26 (22 to 30)25 (21 to 29)35 (29 to 42)35 (29 to 41)
Serogroup C (N=607, 615, 554, 539)18 (15 to 20)13 (11 to 15)36 (29 to 42)27 (21 to 33)
Serogroup W (N=594, 605, 542, 533)43 (38 to 50)21 (19 to 25)61 (52 to 72)35 (30 to 42)
Serogroup Y (N=593, 600, 545, 539)24 (20 to 28)10 (8.68 to 12)34 (28 to 41)14 (12 to 17)
SecondaryPercentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)

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, 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Percentages of subjectsMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)
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)
SecondaryPercentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

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, 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.

Time frame:
1 month postvaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Percentages of subjectsMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)
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)
SecondaryGMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)

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-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.

Time frame:
1 month postvaccination
Reported as:
Geometric mean · Titers
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
TitersMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)
Serogroup A (N=291, 606)64 (51 to 81)27 (23 to 82)
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)
SecondaryPercentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.

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, after 1 dose treatment.

Time frame:
Study days 1 to 7
Reported as:
Number · Percentages of subjects
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Percentages of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine (1 Dose)
Injection site pain3335
Injection site erythema2718
Injection site induration1818
Change in Eating Habits (N=683, 671)910
Sleepiness (N=692, 684)1618
Irritability (N=692, 684)2122
Vomiting (N=692, 684)33
Diarrhea (N=692, 684)78
Arthralgia34
Headache56
Rash45
Fever ( ≥ 38C ; N=692, 684)22
Fever ( ≥ 40.0C )00
Stayed home (N=682, 670)32
Analgesic/Antipyretic medication used1113
SecondaryPercentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.

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 after 1 dose treatment.

Time frame:
Study days 1 to 7
Reported as:
Number · Percenatage of subjects
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Percenatage of subjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine (1 Dose)
Injection site pain3945
Injection site erythema2822
Injection site induration1713
Chills55
Nausea86
Malaise1411
Myalgia1010
Arthralgia64
Headache1813
Rash53
Fever ( ≥ 38C ; N=582, 570)22
Fever ( ≥ 40.0C ; N=582, 570)01
Stayed home (N=575, 566)32
Analgesic/Antipyretic medication used910
SecondaryPercentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.

Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.

Time frame:
day 1 to study termination (day 240)
Reported as:
Number · Percentage of Subjects
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Percentage of SubjectsMenACWY-CRM (1 Dose)Licensed Polysaccharide Vaccine (1 Dose)
Any AEs2624
Possibly probably related AEs55
SAEs11
AEs leading to discontinuation00
Possibly probably related SAEs00
Death00

Adverse events

Collected over All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MenACWY-CRM (2 Doses)—2/351 (0.6%)253/351 (72.1%)
MenACWY-CRM (1 Dose)_2 to 5 Years—5/693 (0.7%)424/693 (61.2%)
MenACWY-CRM (1 Dose)_6 to 10 Years—3/582 (0.5%)340/582 (58.4%)
Licensed Polysaccharide Vaccine_2 to 5 Years—5/684 (0.7%)419/684 (61.3%)
Licensed Polysaccharide Vaccine_6 to 10 Years—2/571 (0.4%)342/571 (59.9%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)_2 to 5 YearsMenACWY-CRM (1 Dose)_6 to 10 YearsLicensed Polysaccharide Vaccine_2 to 5 YearsLicensed Polysaccharide Vaccine_6 to 10 Years
PneumoniaInfections and infestations0/3512/6930/5821/6840/571
DehydrationMetabolism and nutrition disorders0/3512/6930/5820/6840/571
Intestinal obstructionGastrointestinal disorders1/3510/6930/5820/6840/571
BronchopneumoniaInfections and infestations1/3510/6930/5820/6840/571
Parvovirus infectionInfections and infestations1/3510/6930/5820/6840/571
Mouth CystGastrointestinal disorders0/3510/6930/5820/6841/571
Psychiatric SymptomPsychiatric disorders0/3510/6930/5820/6841/571
Shigella infectionInfections and infestations0/3510/6931/5820/6840/571
Cellulitis StaphylococcalInfections and infestations0/3510/6931/5820/6840/571
Adrenal HaematomaInjury, poisoning and procedural complications0/3510/6931/5820/6840/571
Most frequent other events
Showing 10 of 17
Most frequent other events
EventMenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)_2 to 5 YearsMenACWY-CRM (1 Dose)_6 to 10 YearsLicensed Polysaccharide Vaccine_2 to 5 YearsLicensed Polysaccharide Vaccine_6 to 10 Years
injection site painGeneral disorders151/351226/693226/582241/684256/571
injection site erythemaGeneral disorders131/351186/693164/582170/684126/571
irritablilityGeneral disorders98/351147/6930/582152/6840/571
injection site indurationGeneral disorders82/351126/69397/582126/68473/571
somnolenceNervous system disorders81/351109/6930/582126/6840/571
headacheNervous system disorders27/35137/693105/58239/68479/571
eating disorderPsychiatric disorders56/35164/6930/58269/6840/571
mailaiseGeneral disorders0/3510/69382/5820/68462/571
MYALGIAMusculoskeletal and connective tissue disorders0/3510/69362/5820/68459/571
diarrhoeaGastrointestinal disorders35/35152/6934/58255/6842/571

Baseline characteristics

Age, Continuous
Age, Continuous(years)MenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)Licensed Polysaccharide VaccineTotal
Mean3.5 ± 1.15.5 ± 2.55.6 ± 2.65.3 ± 2.5
Sex: Female, Male
Sex: Female, Male(Participants)MenACWY-CRM (2 Doses)MenACWY-CRM (1 Dose)Licensed Polysaccharide VaccineTotal
Female1716225801373
Male1886566901534
08

Study locations

68 sites
  • Children's Investigational Reserach Program
    Bentonville, Arkansas 72712, United States
  • Arkansas Pediatric Research Group
    Little Rock, Arkansas 72205, United States
  • Premier Health Research Center
    Downey, California 90241, United States
  • Kaiser Permanente - Fremont
    Fremont, California 94538, United States
  • Kaiser Permanente - Fresno
    Fresno, California 93726, United States
  • Kaiser Permanente - Hayward
    Hayward, California 94545, United States
  • Kaiser Permanente - Oakland
    Oakland, California 94611, United States
  • Kaiser Permanente - Pleasanton
    Pleasanton, California 94566, United States
  • Kaiser Permanente - San Francisco
    San Francisco, California 94115, United States
  • Kaiser Permanente - San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente - Aurora
    Aurora, Colorado 80012, United States
  • 1st Allergy & Clinical Research
    Centennial, Colorado 80112, United States
  • Longmont Medical Research Network
    Longmont, Colorado 80501, United States
  • 1st Allergy & Clinical Research
    Thornton, Colorado 80233, United States
  • Kaiser Permanente - Westminister
    Westminister, Colorado 80234, United States
  • Kentucky Pediatric Research Center
    Bardstown, Kentucky 40004, United States
  • Physicians to Children & Adolescents
    Springfield, Kentucky 40004, United States
  • Benchmark Research
    Metairie, Louisiana 70006, United States
  • St. Louis University School of Medicine
    St. Louis, Missouri 63104, United States
  • Meridian Clinical Research LLC
    Omaha, Nebraska 68134, United States
  • Legacy Pediatrics
    Rochester, New York 14618, United States
  • Duke University Medical Center
    Durham, North Carolina 27704, United States
  • Durham Pediatrics
    Durham, North Carolina 27704, United States
  • Regional Pediatric Associates PA
    Durham, North Carolina 27704, United States
  • Odyssey Research
    Fargo, North Dakota 58103, United States
  • Dr. Senders and Associates
    Cleveland, Ohio 44121, United States
  • Calcagno Research & Development
    Gresham, Oregon 97030, United States
  • Children's Health Care - West
    Erie, Pennsylvania 16505, United States
  • University Of Pittsburgh Medical Center
    Greenville, Pennsylvania 16125, United States
  • Family Healthcare Partners
    Grove City, Pennsylvania 16127, United States
  • Pediatric Associates of Latrobe
    Latrobe, Pennsylvania 15650, United States
  • Pediatric Alliance PC
    Pittsburgh, Pennsylvania 15217, United States
  • Pediatric Alliance PC
    Pittsburgh, Pennsylvania 15220, United States
  • South Hills Pediatrics
    Pittsburgh, Pennsylvania 15227, United States
  • Pediatric Alliance PC
    Pittsburgh, Pennsylvania 15236, United States
  • Primary Physicians Research Inc.
    Pittsburgh, Pennsylvania 15241, United States
  • Primary Physicians Research Inc.
    Pittsburg, Pennsylvania 15237, United States
  • Laurel Pediatrics
    Uniontown, Pennsylvania 15401, United States
  • Family Practice Medical Associates South
    Upper St. Clair, Pennsylvania 15241, United States
  • Children's Community Pediatrics
    Wexford, Pennsylvania 15090, United States
  • Jackson Clinic Professional Association
    Jackson, Tennessee 38305, United States
  • Benchmark Research Ft. Worth
    Fort Worth, Texas 76135, United States
  • Benchmark Research San Angelo
    San Angelo, Texas 76904, United States
  • Jean Brown Research
    Clinton, Utah 84015, United States
  • Wee Care Pediatrics
    Layton, Utah 84041, United States
  • Cottonwood Pediatrics
    Murray, Utah 84107, United States
  • J. Lewis Research Inc.
    Salt Lake City, Utah 84109, United States
  • J. Lewis Research Inc.
    Salt Lake City, Utah 84121, United States
  • Jean Brown Research
    Salt Lake City, Utah 84124, United States
  • Copperview Medical Center
    South Jordan, Utah 84095, United States
  • Rockwood Clinic
    Spokane, Washington 99202, United States
  • Rockwood Clinic North
    Spokane, Washington 99218, United States
  • TASC Research Services Inc.
    Surrey, British Columbia V3R 8P8, Canada
  • Manitoba Clinic
    Winnipeg, Manitoba R3A 1M3, Canada
  • Clinical Trials Research Center
    Halifax, Nova Scotia B3K 6R8, Canada
  • Colchester Regional Hospital
    Truro, Nova Scotia B2N 1L2, Canada
  • Albion Finch Medical Centre
    Etobicoke, Ontario M9V 4B4, Canada
  • Children's Hospital of Western Ontario
    London, Ontario N6A 1V2, Canada
  • SKDS Research In.
    Newmarket, Ontario L3Y 5G8, Canada
  • Herridge Community Health Clinic
    Ottawa, Ontario K1S 0G8, Canada
  • Sarnia Institute of Clinical Research
    Sarnia, Ontario N7T 4X3, Canada
  • Medicor Research Inc.
    Sudbury, Ontario P3E 1H5, Canada
  • Resolve Research Solutions
    Toronto, Ontario M5G 1N8, Canada
  • Resolve Research Solutions
    Toronto, Ontario M5M 1B2, Canada
  • Queen Elizabeth Hospital
    Charlottetown, Prince Edward Island C1A 8T5, Canada
  • Royal University Hospital
    Saskatoon, Saskatchewan S7N 0W8, Canada
  • Commonwealth Medical Clinic
    Mount Pearl, A1N 1W7, Canada
  • White Hills Medical Clinic
    Saint John's, A1A 3R5, Canada
09

References and documents

Publications

  • Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29. PubMed 20943209 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00616421
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Feb 15, 2008
Start date
Mar 2008
Primary completion
Apr 2009
Completion
Oct 2009
Results posted
Jun 9, 2011
Last update
Feb 15, 2016

Study contacts

Novartis Vaccines and Diagnostics
study director · Novartis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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