Clinical trial NCT00329849: Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: Meningitis
children
vaccine
safety
efficacy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age


Eligibility criteria: Inclusion Criteria:

* Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
* Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
* Good health as determined by the clinical judgment of the investigator.

Exclusion Criteria:

Individuals not eligible to be enrolled into the study were those:

* whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
* whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period;
* who had a previous or suspected disease caused by N meningitidis;
* who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
* who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
* who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
* who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
* who had received a live viral vaccine within 60 days prior to enrollment;
* who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment;
* who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
* who had epilepsy or any progressive neurological disease;
* who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
* who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
* receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose \>1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
* receipt of immunostimulants;
* receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
* common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
* who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time;
* who had Down syndrome or other known cytogenic disorders;
* whose families were planning to leave the area of the study site before the end of the study period;
* who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: 1 month after vaccination (day 29)
measure: Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
timeFrame: Day 1 to 7 postvaccination
Secondary outcomes:
measure: Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: Day 1 and 29
measure: The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: Day 1 and 29
measure: Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: Day 181
measure: The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: Day 181
measure: Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
timeFrame: Day 1 to 7 postvaccination
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: FUNCEI, French 3085
city: Cordoba
country: Argentina
facility: Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464
city: La Plata
country: Argentina
facility: Hospital de Pediatria "Sor Maria Ludovica", Calle 14 N1631,(1900)
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines & Diagnostics
role: STUDY_CHAIR
References:
citation: Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4.