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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MenACWY-CRM

Group Type EXPERIMENTAL

MenACWY-CRM

Intervention Type BIOLOGICAL

MenACWY-CRM

MenACWY-TT

Group Type ACTIVE_COMPARATOR

MenACWY-TT

Intervention Type BIOLOGICAL

MenACWY-TT

Interventions

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MenACWY-CRM

Intervention Type BIOLOGICAL

MenACWY-TT

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes