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CompletedNCT00518180Updated May 18, 2016Results posted

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

A Phase 3 interventional study of Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine in Meningococcal Meningitis, Human Papillomavirus Infection and Pertussis, sponsored by Novartis Vaccines. Completed at 1 site in Costa Rica. Open to participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-18.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,620
Allocation
Randomized
Ages
11 Years to 18 Years
Sex
All
01

Study summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents

02

Conditions studied

  • Meningococcal Meningitis
  • Human Papillomavirus Infection
  • Pertussis
  • Tetanus

Keywords

  • Meningococcal
  • meningitis
  • vaccine
  • adolescents
03

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 1,620 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.

Browse Whooping Cough 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
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adolescents 11-18 years of age
  • virgins (both male and female) with no intention of becoming sexually active during the study period
  • who have been properly vaccinated against diphtheria, tetanus, pertussis

Exclusion criteria

Exclusion Criteria:

  • who had a previous confirmed or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine
  • who have received prior human papillomavirus (HPV) vaccine;
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired
  • 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
None (open label)
Enrollment
1,620 participants (actual)

Study arms

  • Experimental
    MenACWY + Tdap + HPV

    Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6

    Biological: Novartis Meningococcal ACWY Conjugate Vaccine

  • Experimental
    MenACWY →Tdap → HPV

    Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8

    Biological: Novartis Meningococcal ACWY Conjugate Vaccine

  • Experimental
    Tdap →MenACWY → HPV

    Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8

    Biological: Tdap Vaccine

Interventions

  • BiologicalNovartis Meningococcal ACWY Conjugate Vaccine

    One dose of vaccine administered intramuscularly

  • BiologicalTdap Vaccine

    One dose of vaccine administered intramuscularly

  • BiologicalNovartis Meningococcal ACWY Conjugate Vaccine

    One dose of vaccine administered intramuscularly

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse

    Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

    Time frame: 1 month post MenACWY vaccination

  2. Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL

    To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone

    Time frame: 1 month post Tdap vaccination

  3. Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)

    To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone

    Time frame: 1 month post Tdap vaccination

Secondary outcomes

  1. Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups

    The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.

    Time frame: 1 month post MenACWY vaccination

  2. Percentage of Subjects With Anti-HPV Seroconversion

    To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer \< type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.

    Time frame: 1 month post third HPV vaccination

  3. Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay

    To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)

    Time frame: 1 month post third HPV vaccination

  4. Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups

    The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.

    Time frame: 1 month post MenACWY vaccination

  5. The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus

    The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.

    Time frame: 1 month post Tdap vaccination

  6. Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus

    To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.

    Time frame: 1 month post Tdap vaccination

  7. Geometric Mean Titers (GMT) of Pertussis Antigens

    To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.

    Time frame: 1 month post Tdap vaccination

  8. Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN

    To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.

    Time frame: 1 month post Tdap vaccination

  9. Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.

    Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.

    Time frame: Days 1 to 7

  10. Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination

    Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.

    Time frame: Days 1 to 7

07

Results

Posted Oct 4, 2010

Participant flow

Participants were enrolled at a single center in Costa Rica.

Participant flow — Overall Study
MilestoneMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPV
Started540541539
Completed475472457
Not completed656982
Withdrew: Withdrawal by subject293042
Withdrew: Lost to follow-up302834
Withdrew: Administrative reason022
Withdrew: Protocol violation574
Withdrew: Unable to classify020
Withdrew: Adverse event100

Outcome measures

PrimaryPercentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse

Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time frame:
1 month post MenACWY vaccination
Reported as:
Number · Percentage of participants
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Percentage of participantsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPV
Serogroup A (N=494, 486, 458)80 (76 to 84)82 (78 to 85)87 (83 to 90)
Serogroup C (N=476, 472, 457)83 (79 to 86)84 (81 to 88)84 (80 to 87)
Serogroup W (N=487, 474, 458)77 (73 to 80)81 (77 to 84)65 (61 to 70)
Serogroup Y (N=493, 487, 460)83 (79 to 86)82 (79 to 86)78 (74 to 82)
Statistical analysis
  • MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV · Vaccine group differences (%): -2 · 95% CI -6 to 3
  • MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV · Vaccine group differences (%): -1 · 95% CI -6 to 3
  • MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV · Vaccine group differences (%): -4 · 95% CI -9 to 1
  • MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV · Vaccine group differences (%): 0 · 95% CI -4 to 5
  • MenACWY→Tdap→HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): 5 · 95% CI 1 to 10
  • MenACWY→Tdap→HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): -1 · 95% CI -6 to 4
  • MenACWY→Tdap→HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): -16 · 95% CI -21 to -10
  • MenACWY→Tdap→HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): -4 · 95% CI -9 to 1
PrimaryPercentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL

To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone

Time frame:
1 month post Tdap vaccination
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Percentage of subjectsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPV
Diphtheria100 (99 to 100)100 (99 to 100)98 (96 to 99)
Tetanus100 (99 to 100)100 (99 to 100)100 (99 to 100)
Statistical analysis
  • MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): 2 · 95% CI 1 to 4
  • MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV · Vaccine group differences (%): 0 · 95% CI -1 to 1
SecondaryEffect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups

The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.

Time frame:
1 month post MenACWY vaccination
Reported as:
Geometric mean · Titers
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
TitersMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Serogroup A (N=494, 486, 458)62 (52 to 74)67 (56 to 80)95 (79 to 113)
Serogroup C (N=476, 472, 457)66 (56 to 77)70 (60 to 83)68 (58 to 79)
Serogroup W (N=487, 474, 458)146 (129 to 165)159 (140 to 181)104 (91 to 119)
Serogroup Y (N=493, 487, 460)72 (62 to 84)81 (70 to 95)57 (49 to 67)
SecondaryPercentage of Subjects With Anti-HPV Seroconversion

To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer \< type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.

Time frame:
1 month post third HPV vaccination
Reported as:
Number · Percentage of subjects
Percentage of Subjects With Anti-HPV Seroconversion
Percentage of subjectsMenACWY+Tdap+HPVHPV Alone
HPV 6 (N=361, 737)99 (98 to 100)100 (99 to 100)
HPV 11 (N=362, 744)100 (99 to 100)100 (99 to 100)
HPV 16 (N=360, 744)100 (99 to 100)100 (99 to 100)
HPV 18 (N=364, 743)100 (98 to 100)99 (99 to 100)
SecondaryGeometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay

To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)

Time frame:
1 month post third HPV vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
TitersMenACWY+Tdap+HPVHPV Alone
HPV 6 (N=361, 737)1059 (926 to 1212)1461 (1327 to 1608)
HPV 11 (N=362, 744)1264 (1134 to 1408)1701 (1575 to 1837)
HPV 16 (N=360, 744)5286 (4705 to 5939)6590 (6068 to 7158)
HPV 18 (N=364, 743)908 (798 to 1032)1117 (1019 to 1224)
SecondaryPercentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups

The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.

Time frame:
1 month post MenACWY vaccination
Reported as:
Number · Percentage of subjects
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Percentage of subjectsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Serogroup A hSBA ≥ 1:8 (N=494, 486, 458)81 (78 to 85)82 (79 to 86)89 (85 to 91)
Serogroup C hSBA ≥ 1:8 (N=476, 472, 457)92 (89 to 94)90 (87 to 93)93 (90 to 95)
Serogroup W hSBA ≥ 1:8 (N=487, 474, 458)98 (96 to 99)99 (98 to 100)95 (93 to 97)
Serogroup Y hSBA ≥ 1:8 (N=493, 487, 460)93 (90 to 95)93 (90 to 95)92 (90 to 95)
Serogroup A hSBA ≥ 1:4 (N=408, 404, 412)83 (79 to 86)83 (79 to 86)90 (87 to 93)
Serogroup C hSBA ≥ 1:4 (N=456, 447, 430)92 (90 to 94)92 (89 to 94)94 (92 to 96)
Serogroup W hSBA ≥ 1:4 (N=478, 471, 443)98 (97 to 99)99 (98 to 100)97 (95 to 98)
Serogroup Y hSBA ≥ 1:4 (N=465, 456, 438)94 (92 to 96)94 (91 to 96)95 (93 to 97)
SecondaryThe Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus

The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.

Time frame:
1 month post Tdap vaccination
Reported as:
Number · Percentages of subjects
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
Percentages of subjectsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Diphtheria (% ≥1.0 IU/mL)100 (99 to 100)100 (99 to 100)98 (96 to 99)
Tetanus (% ≥1.0 IU/mL)100 (99 to 100)100 (99 to 100)100 (99 to 100)
SecondaryGeometric Mean Concentrations (GMC) for Diphtheria and Tetanus

To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.

Time frame:
1 month post Tdap vaccination
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
IU/mLMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Diphtheria37 (34 to 41)10 (9.12 to 12)10 (9.38 to 11)
Tetanus8.75 (8.23 to 9.3)12 (11 to 13)10 (9.46 to 11)
SecondaryGeometric Mean Titers (GMT) of Pertussis Antigens

To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.

Time frame:
1 month post Tdap vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMT) of Pertussis Antigens
TitersMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Anti-PT (N=479, 451, 477)51 (47 to 55)79 (72 to 87)63 (58 to 69)
Anti-FHA (N=489, 457, 485)342 (310 to 376)1106 (989 to 1238)511 (464 to 563)
Anti-PRN (N=492, 458, 487)819 (727 to 923)1563 (1390 to 1758)1197 (1061 to 1350)
SecondaryPercentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN

To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.

Time frame:
1 month post Tdap vaccination
Reported as:
Number · Percentages of subjects
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Percentages of subjectsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY→HPV
Anti-PT (N=479, 451, 477)83 (79 to 86)89 (86 to 92)86 (83 to 89)
Anti-FHA (N=489, 457, 485)67 (63 to 71)90 (87 to 93)78 (74 to 82)
Anti-PRN (N=492, 458, 487)86 (83 to 89)95 (92 to 97)89 (85 to 91)
PrimaryGeometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)

To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone

Time frame:
1 month post Tdap vaccination
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
IU/mLMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPV
Anti-PT (N=479, 451, 477)51 (47 to 55)79 (72 to 87)63 (58 to 69)
Anti-FHA (N=489, 457, 485)342 (310 to 376)1106 (989 to 1238)511 (464 to 563)
Anti-PRN (N=492, 458, 487)819 (727 to 923)1563 (1390 to 1758)1197 (1061 to 1350)
Statistical analysis
  • MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV · Vaccine group ratio: 0.8 · 95% CI 0.72 to 0.9
  • MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV · Vaccine group ratio: 0.68 · 95% CI 0.58 to 0.81
  • MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV · Vaccine group ratio: 0.67 · 95% CI 0.58 to 0.76
SecondaryNumber of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.

Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.

Time frame:
Days 1 to 7
Reported as:
Number · Subjects
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
SubjectsMenACWY+Tdap+HPVMenACWY→Tdap → HPVTdap → MenACWY →HPV
Injection site pain MenACWY263246239
Injection site pain Tdap367310383
Injection site erythema MenACWY686664
Injection site erythema Tdap783870
Injection site induration MenACWY687063
Injection site induration Tdap9064110
Chills post-vaccination 1776670
Chills post-vaccination 204245
Nausea post-vaccination 1887282
Nausea post-vaccination 204264
Malaise post-vaccination 1133110115
Malaise post-vaccination 209188
Myalgia post-vaccination 1146104142
Myalgia post-vaccination 208182
Arthralgia post-vaccination 1946276
Arthralgia post-vaccination 205252
Headache post-vaccination 1217194200
Headache post-vaccination 20125138
Rash post-vaccination 1211720
Rash post-vaccination 201513
Fever ≥ 38°Celsius post-vaccination 1271917
Fever ≥ 38°Celsius post-vaccination 202530
Analgesic/Antipyretic Med. Used post-vaccination 11108396
Analgesic/Antipyretic Med. Used post-vaccination 205849
SecondaryNumber of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination

Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.

Time frame:
Days 1 to 7
Reported as:
Number · Subjects
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
SubjectsMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY → HPV
Injection site pain postvaccination 1265180204
Injection site erythema postvaccination 1743642
Injection site induration postvaccination 1542726
Injection site pain (N=498, 483, 468) postvac 2208208189
Injection site erythema postvaccination 2624857
Injection site induration postvaccination 2463750
Injection site pain postvaccination 3229227208
Injection site erythema postvaccination 3605655
Injection site induration postvaccination 3604748
Chills postvaccination 1772730
Nausea postvaccination 1883932
Malaise postvaccination 11334955
Myalgia postvaccination 11463256
Arthralgia postvaccination 1943328
Headache postvaccination 12179397
Rash postvaccination 12176
Fever (≥ 38°C) postvaccination 1272123
Stayed home postvaccination 11102634
Chills postvaccination 2232226
Nausea postvaccination 2383029
Malaise postvaccination 2534534
Myalgia postvaccination 2423851
Arthralgia postvaccination 2302821
Headache postvaccination 2887871
Rash postvaccination 24119
Fever (≥ 38°C) postvaccination 2172222
Chills postvaccination 3222425
Nausea postvaccination 3323534
Malaise postvaccination 3495041
Myalgia postvaccination 3534937
Arthralgia postvaccination 3372630
Headache postvaccination 3798579
Rash postvaccination 39710
Fever (≥ 38°C) postvaccination 3201625

Adverse events

Collected over During the 30-day period following each vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MenACWY+Tdap+HPV—1/540 (0.2%)495/540 (91.7%)
MenACWY→Tdap→HPV—7/541 (1.3%)489/541 (90.4%)
Tdap → MenACWY → HPV—3/539 (0.6%)482/539 (89.4%)
Most frequent serious events
Most frequent serious events
EventMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY → HPV
APPENDICITISInfections and infestations0/5402/5410/539
ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications0/5400/5411/539
ABORTION SPONTANEOUSPregnancy, puerperium and perinatal conditions0/5401/5411/539
HYDRONEPHROSISRenal and urinary disorders0/5400/5411/539
CUSHING'S SYNDROMEEndocrine disorders1/5400/5410/539
PITUITARY TUMOUR BENIGNNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/5400/5410/539
BEZOARGastrointestinal disorders0/5401/5410/539
HAEMORRHAGIC OVARIAN CYSTReproductive system and breast disorders0/5401/5410/539
TESTICULAR TORSIONReproductive system and breast disorders0/5401/5410/539
BEHCET'S SYNDROMEVascular disorders0/5401/5410/539
Most frequent other events
Showing 10 of 17
Most frequent other events
EventMenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap → MenACWY → HPV
INJECTION SITE PAIN HPVGeneral disorders387/540320/541313/539
INJECTION SITE PAIN TdapGeneral disorders368/540310/541383/539
HEADACHENervous system disorders260/540284/541278/539
INJECTION SITE PAIN MENVEOGeneral disorders264/540246/541239/539
MALAISEGeneral disorders171/540209/541194/539
MYALGIAMusculoskeletal and connective tissue disorders178/540187/541200/539
NAUSEAGastrointestinal disorders124/540133/541142/539
INJECTION SITE ERYTHEMA HPVGeneral disorders134/540105/541101/539
ARTHRALGIAMusculoskeletal and connective tissue disorders119/540132/541131/539
CHILLSGeneral disorders100/540117/541130/539

Baseline characteristics

Age, Continuous
Age, Continuous(years)MenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPVTotal
Mean13.9 ± 2.113.9 ± 2.213.8 ± 2.213.9 ± 2.1
Sex: Female, Male
Sex: Female, Male(Participants)MenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPVTotal
Female308309307924
Male232232232696
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)MenACWY+Tdap+HPVMenACWY→Tdap→HPVTdap →MenACWY → HPVTotal
Hispanic5395415391619
Black1001
08

Study locations

1 site
  • San Jose, Costa Rica
    San Jose, Costa Rica
09

References and documents

Publications

  • Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26. PubMed 20189491 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00518180
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Aug 20, 2007
Start date
Jul 2007
Primary completion
Apr 2008
Completion
Oct 2008
Results posted
Oct 4, 2010
Last update
May 18, 2016

Study contacts

Novartis Vaccines and Diagnostics
study director · Novartis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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