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: 1. Healthy children between 12 months and 15 months old who were born with an estimated gestational age ≥ 37 weeks; 2. Parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained; 3. 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); 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 are 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 may 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. 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). 9. Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who have 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 is 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.

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.