Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Phase 3

Completed

Conditions: Meningococcal Infection
Meningitis

Registration Number: NCT00806195

Lead Sponsor: Novartis

Brief Summary: The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7744

Inclusion Criteria

healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
who are available for all visits scheduled in the study;
who are in good health as determined by medical history and physical assessment.

Exclusion Criteria

who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
who have a previous confirmed or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);
who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
1. receipt of any immunosuppressive therapy at any time since birth
2. receipt of immunostimulants at any time since birth
3. receipt of any systemic corticosteroid since birth;
who have a suspected or known HIV infection or HIV related disease;
who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
who have any history of seizure;
who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
who are relatives of site research staff working on this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination	15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age	To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

Secondary Outcome Measures

Name	Time	Method
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination	15 minutes to Day 7	To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination	Day 1 (2 months of age) to 18 months of age	Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.
Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period	Day 1 (2 months of age) to 18 months of age	To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.

Trial Locations

Locations (153): 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
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Birmingham, Alabama, United States
43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
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Dothan, Alabama, United States
81 Cholla Pediatrics 2167 West Orange Grove Road
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Tuscon, Arizona, United States
55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
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Benton, Arkansas, United States
21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
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Fayetteville, Arkansas, United States
30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
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Fort Smith, Arkansas, United States
14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
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Jonesboro, Arkansas, United States
170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
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Little Rock, Arkansas, United States
3 Arkansas Pediatric Clinic 500 S. University Suite 200
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Little Rock, Arkansas, United States
179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
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Buena Park, California, United States
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6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
🇺🇸Birmingham, Alabama, United States