Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Enrollment
Sex
Ages
Volunteers
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):
- receipt of any immunosuppressive therapy at any time since birth
- receipt of immunostimulants at any time since birth
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
7,744 participants in 6 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal