NCT01994629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2015

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

November 11, 2013

Results QC Date

August 5, 2015

Last Update Submit

October 2, 2015

Conditions

Meningococcal Disease

Keywords

meningococcal diseasechildrenvaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1 to Day 7 post-vaccination

Secondary Outcomes (9)

  • 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.

    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.

    Day 29 and Day 180 post-vaccination

  • 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.

    Day 1, Day 29 and Day 180 post-vaccination

  • 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.

    Day 1, Day 29 and Day 180 post-vaccination

  • 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.

    Day 1, Day 29 and Day 180 post-vaccination

  • +4 more secondary outcomes

Study Arms (2)

MenACWY-CRM

EXPERIMENTAL

MenACWY-CRM

Biological: MenACWY-CRM

MenACWY-TT

ACTIVE COMPARATOR

MenACWY-TT

Biological: MenACWY-TT

Interventions

MenACWY-CRMBIOLOGICAL

MenACWY-CRM

MenACWY-CRM
MenACWY-TTBIOLOGICAL

MenACWY-TT

MenACWY-TT

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks.
  • Parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements.
  • 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).
  • In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

You may not qualify if:

  • Previous confirmed or suspected disease caused by N. meningitidis.
  • Previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease.
  • Previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
  • 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).
  • 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).
  • Major congenital defect or a serious chronic disease.
  • History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.
  • 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).
  • Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any bleeding disorder which was considered as a contraindication to intramuscular injection.
  • Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrollment.
  • Systemic antibiotic treatment within 7 days prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dipartimento di Prevenzione S C Igiene e Sanita Pubblica

Chiavari, ASL4 Chiavarese Regione Liguria Corso Dante 163, 16043, Italy

Location

Ospedale Maggiore della Carita

Novara, Corso Mazzini 18, 28100, Italy

Location

ASL Sassari 1 Servizio Igiene Pubblica

Sassari, Via Amendola 55, 07100, Italy

Location

AOU Meyer Dip Scienze per la Salute della Donna e Bambino

Florence, Viale Pieraccini 24, 50139, Italy

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenACWY-CRM vaccinetetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

November 4, 2015

Results First Posted

November 4, 2015

Record last verified: 2015-10

Locations

IT(4)