Clinical trial NCT01994629: Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Official title: A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: meningococcal disease
children
vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 202
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old healthy toddlers.


Eligibility criteria: Inclusion Criteria:

1. Healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks.
2. Parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements.
3. Parents/legal guardian available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls).
4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

1. Previous confirmed or suspected disease caused by N. meningitidis.
2. Previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease.
3. Previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. Received within 90 days prior to enrollment or were expected to receive during the study period any investigational or non-registered product (drug or vaccine).
5. Received or planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exceptions: Injectable influenza vaccine could be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination).
6. Major congenital defect or a serious chronic disease.
7. History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.
8. Required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids were allowed).
9. Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
11. Any bleeding disorder which was considered as a contraindication to intramuscular injection.
12. Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrollment.
13. Systemic antibiotic treatment within 7 days prior to enrollment.

Primary outcomes:
measure: Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.
timeFrame: Day 1 to Day 7 post-vaccination
Secondary outcomes:
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1, Day 29 and Day 180 post-vaccination
measure: Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 29 and Day 180 post-vaccination
measure: hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1, Day 29 and Day 180 post-vaccination
measure: Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1, Day 29 and Day 180 post-vaccination
measure: Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1, Day 29 and Day 180 post-vaccination
measure: Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 29 and Day 180 post-vaccination
measure: rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1, Day 29 and Day 180 post-vaccination
measure: Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1 (6 hours) to Day 7 post-vaccination
measure: Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
timeFrame: Day 1 to Day 29 or Day 1 to Day 180 post-vaccination
Other outcomes:
Locations:
city: Chiavari
country: Italy
facility: Dipartimento di Prevenzione S C Igiene e Sanita Pubblica
state: ASL4 Chiavarese Regione Liguria Corso Dante 163
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita
state: Corso Mazzini 18
city: Sassari
country: Italy
facility: ASL Sassari 1 Servizio Igiene Pubblica
state: Via Amendola 55
city: Firenze
country: Italy
facility: AOU Meyer Dip Scienze per la Salute della Donna e Bambino
state: Viale Pieraccini 24
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: