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Completed

NCT Number: NCT00518180

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

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

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Key information

Conditions

Meningococcal Meningitis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Human Papillomavirus Infection Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pertussis Respiratory Tract Diseases Respiratory Tract Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tetanus Tumor Virus Infections Urogenital Diseases Virus Diseases Whooping Cough

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Jose, Costa Rica

San José, Costa Rica

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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;

Treatment and study plan

Novartis Meningococcal ACWY Conjugate Vaccine

Biological

One dose of vaccine administered intramuscularly

Tdap vaccine

Biological

One dose of vaccine administered intramuscularly

Primary outcomes

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

    Time frame: 1 month post MenACWY vaccination

    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.

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

    Time frame: 1 month post Tdap vaccination

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

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

    Time frame: 1 month post Tdap vaccination

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

Secondary outcomes

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

    Time frame: 1 month post MenACWY vaccination

    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.

  2. Percentage of Subjects With Anti-HPV Seroconversion

    Time frame: 1 month post third HPV vaccination

    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.

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

    Time frame: 1 month post third HPV vaccination

    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.)

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

    Time frame: 1 month post MenACWY 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.

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

    Time frame: 1 month post Tdap vaccination

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

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

    Time frame: 1 month post Tdap vaccination

    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.

  7. Geometric Mean Titers (GMT) of Pertussis Antigens

    Time frame: 1 month post Tdap vaccination

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

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

    Time frame: 1 month post Tdap vaccination

    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.

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

    Time frame: Days 1 to 7

    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.

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

    Time frame: Days 1 to 7

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2007
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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