Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

Phase 2CompletedNCT01994629

Novartis Vaccines202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

202

Conditions

Meningococcal Disease

Interventions

MenACWY-CRMBIOLOGICAL

MenACWY-CRM

MenACWY-TTBIOLOGICAL

MenACWY-TT

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 15 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Dipartimento di Prevenzione S C Igiene e Sanita Pubblica

Chiavari, ASL4 Chiavarese Regione Liguria Corso Dante 163, Italy

Ospedale Maggiore della Carita

Novara, Corso Mazzini 18, Italy

ASL Sassari 1 Servizio Igiene Pubblica

Sassari, Via Amendola 55, Italy

AOU Meyer Dip Scienze per la Salute della Donna e Bambino

Florence, Viale Pieraccini 24, Italy

Outcomes

Primary Outcomes

Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.

Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.

Time frame: Day 1 to Day 7 post-vaccination

Secondary Outcomes

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.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.

Time frame: Day 1, Day 29 and Day 180 post-vaccination

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.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer \< 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.

Time frame: Day 29 and Day 180 post-vaccination

Data from ClinicalTrials.gov

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