Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments menacwy-crm, menacwy-tt
Phase phase 2
Sponsor Novartis Vaccines
Start date November 2013
End date April 2014
Trial size 202 participants
Trial identifier NCT01994629, 2013-000862-13, V59_67

Summary

Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-CRM and Meningococcal ACWY-TT in 12-15 month old toddlers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
MenACWY-CRM
menacwy-crm
MenACWY-CRM
(Active Comparator)
MenACWY-TT
menacwy-tt
MenACWY-TT

Primary Outcomes

Measure
Percentage of subjects with at least one severe solicited Adverse Event reported
time frame: between 6 hours and day 7 post vaccination

Secondary Outcomes

Measure
hSBA titer ≥ 8 against serogroups A, C, W, Y
time frame: day 29 and day 180 post vaccination
Percentage of subjects with hSBA seroresponse against serogroups A, C, W, Y
time frame: day 29 and day 180 post vaccination
Adverse Events and other indicators of reactogenicity
time frame: Day 1 to Day 180 post vaccination
hSBA GMTs against serogroups A, C, W, Y
time frame: Day 29 and day 180 post vaccination
rSBA titer ≥ 8 against serogroups A, C, W, Y
time frame: Day 29 and day 180 post vaccination
rSBA titer ≥ 128 against serogroups A, C, W, Y
time frame: Day 29 and day 180 post vaccination
Four fold rise of rSBA titers against serogroups A, C, W, Y
time frame: Day 29 and day 180 post vaccination
rSBA GMTs against serogroups A, C, W, Y
time frame: Day 29 and day 180 post vaccination

Eligibility Criteria

Male or female participants from 12 months up to 15 months old.

Inclusion Criteria

  • Healthy children between 12 months and 15 months old who were born with an estimated gestational age ≥ 37 weeks;
  • Parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained;
  • Available for all the visits and complying 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.

Exclusion Criteria

  • 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 are 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 may 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.
  • Requiring 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 are allowed).
  • Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who have 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 is 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Novartis.