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

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

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

One dose of vaccine administered intramuscularly

Novartis Meningococcal ACWY Conjugate Vaccine

Tdap Vaccine

Novartis Vaccines and Diagnostics

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

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

A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents

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.

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

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

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.

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.

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.)

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.

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

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.

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

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.

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.

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

Novartis Vaccines

Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.

The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.

MenACWY+Tdap+HPV

The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.

MenACWY→Tdap→HPV

Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.

Tdap → MenACWY → HPV

The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.

The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.

Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.

Tdap →MenACWY → HPV

Total

Age, Continuous

Sex: Female, Male

Hispanic

Black

Race/Ethnicity, Customized

Posting Director

Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Serogroup A (N=494, 486, 458)

Serogroup C (N=476, 472, 457)

Serogroup W (N=487, 474, 458)

Serogroup Y (N=493, 487, 460)

The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.

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

Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.

The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.

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

The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8

Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.

Tdap → MenACWY→HPV

The analysis was performed on the per-protocol (PP) population.

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

HPV 6 (N=361, 737)

HPV 11 (N=362, 744)

HPV 16 (N=360, 744)

HPV 18 (N=364, 743)

Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.

HPV Alone

Percentage of Subjects With Anti-HPV Seroconversion

The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.

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

Serogroup A hSBA ≥ 1:8 (N=494, 486, 458)

Serogroup C hSBA ≥ 1:8 (N=476, 472, 457)

Serogroup W hSBA ≥ 1:8 (N=487, 474, 458)

Serogroup Y hSBA ≥ 1:8 (N=493, 487, 460)

Serogroup A hSBA ≥ 1:4 (N=408, 404, 412)

Serogroup C hSBA ≥ 1:4 (N=456, 447, 430)

Serogroup W hSBA ≥ 1:4 (N=478, 471, 443)

Serogroup Y hSBA ≥ 1:4 (N=465, 456, 438)

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

Diphtheria (% ≥1.0 IU/mL)

Tetanus (% ≥1.0 IU/mL)

The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus

Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus

Anti-PT (N=479, 451, 477)

Anti-FHA (N=489, 457, 485)

Anti-PRN (N=492, 458, 487)

Geometric Mean Titers (GMT) of Pertussis Antigens

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

Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.

Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.

Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.

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

Injection site pain MenACWY

Injection site pain Tdap

Injection site erythema MenACWY

Injection site erythema Tdap

Injection site induration MenACWY

Injection site induration Tdap

Chills post-vaccination 1

Chills post-vaccination 2

Nausea post-vaccination 1

Nausea post-vaccination 2

Malaise post-vaccination 1

Malaise post-vaccination 2

Myalgia post-vaccination 1

Myalgia post-vaccination 2

Arthralgia post-vaccination 1

Arthralgia post-vaccination 2

Headache post-vaccination 1

Headache post-vaccination 2

Rash post-vaccination 1

Rash post-vaccination 2

Fever ≥ 38°Celsius post-vaccination 1

Fever ≥ 38°Celsius post-vaccination 2

Analgesic/Antipyretic Med. Used post-vaccination 1

Analgesic/Antipyretic Med. Used post-vaccination 2

MenACWY→Tdap → HPV

Tdap → MenACWY →HPV

The analysis was performed on the safety set.

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

Injection site pain postvaccination 1

Injection site erythema postvaccination 1

Injection site induration postvaccination 1

Injection site pain (N=498, 483, 468) postvac 2

Injection site erythema postvaccination 2

Injection site induration postvaccination 2

Injection site pain postvaccination 3

Injection site erythema postvaccination 3

Injection site induration postvaccination 3

Chills postvaccination 1

Nausea postvaccination 1

Malaise postvaccination 1

Myalgia postvaccination 1

Arthralgia postvaccination 1

Headache postvaccination 1

Rash postvaccination 1

Fever (≥ 38°C) postvaccination 1

Stayed home postvaccination 1

Chills postvaccination 2

Nausea postvaccination 2

Malaise postvaccination 2

Myalgia postvaccination 2

Arthralgia postvaccination 2

Headache postvaccination 2

Rash postvaccination 2

Fever (≥ 38°C) postvaccination 2

Chills postvaccination 3

The analysis was performed on the safety population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents	NCT00518180	Meningococcal M... Human Papilloma... Pertussis Tetanus	Novartis Mening... Tdap Vaccine Novartis Mening...	11 Years - 18 Years	Novartis
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents	NCT00518180	Meningococcal M... Human Papilloma... Pertussis Tetanus	Novartis Mening... Tdap Vaccine Novartis Mening...	11 Years - 18 Years	Novartis

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