None listed
Conditions
Interventions
Group 1 Type of group
Subjects will receive four injections of the MenACWY vaccine plus concomitant routine vaccines according to the local vaccination schedule)
Group name:Group 2 Type of group
Patients receive only routine vaccinations according to the local calendar. Routine vaccines cannot include a meningococcal vaccine (eg, serogroup C meningococcal conjugate vaccine).
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS,
Eligibility
Sex/Gender
All
Age
2 Years to 2 Years
Inclusion criteria
Inclusion criteria: • Healthy infants 2 months of age (55 to 89 days). In countries where the children´s series begins at 6 weeks of age, the inclusion window for age is 37 to 71 days. Babies must have been born after a full-term pregnancy with an estimated gestational age> 37 weeks and a weight> 2.5 kg at birth; • your parent or legal representative must have given your informed written consent after the nature of the study has been explained to you; • must be available for all scheduled study visits; • must have a good state of health, as determined by: the medical history, the physical examination, the clinical criteria of the investigator.
Exclusion criteria
Exclusion criteria: • must not have previously received any meningococcal or D, T, P, IPV or OPV vaccine, H. influenzae type b (Hib) or Pneumococcus; previous doses of BCG (one) and / or HBV (two) are allowed • must not have a confirmed or suspected previous illness caused by N. memngitidis. C. diphtheriae, C. tetani, polio virus, hepatitis B, Hib, Pneumococcus or B. permssis (history of confirmed laboratory tests, or clinical condition of paroxysmal cough for a period of 2 weeks or more associated with apnea or pertussis) ; • must not have had contact at home and / or close exposure with any that have confirmed laboratory tests of N. meningitidis (serogroups A, C, W, Y), B. pertussis, Hib, C. diphtheriae, poliomyelitis or infection pneumococcal at any time from birth; • must not have a history of anaphylactic shock, asthma, hives or other allergic reaction after previous vaccinations, or known hypersensitivity to any of the components of the vaccine; • must not have experienced significant acute or chronic infection within the previous 7 days, nor should they have experienced fever (axillary temperature> 38.0´C [100.4 ° F]) within the previous 3 days; • should not have or suspect any serious (eg leukemia, lymphomas) or chronic disease (eg, with signs of heart disease, kidney failure, severe malnutrition or insulin-dependent diabetes), progressive neurological disease or genetic abnormality / known cytogenic disorders (eg, Down syndrome); • should not have or suspect an autoimmune disease or persistent dysfunction / alteration of immune function caused (for example) by: having received some immunosuppressive therapy at any time since birth, having received immunostimulants at any time since birth, having received some systemic corticosteroid from birth; • should not suspect or know of an HIV infection or HIV-related disease; • must not have received blood, blood products and / or plasma derivatives, or any parenteral immunoglobulin preparations; • must not have a known hemorrhagic diathesis, or any condition that may be associated with a prolonged bleeding time; • They should not have a history of seizures or seizures; • Your parents / legal representatives should not have plans to leave the study center area before the end of the study period; • they must not have any condition that, in the opinion of the researcher, may interfere with the evaluation of the objectives of the study; • They should not have received any investigational agent or vaccine from birth, nor should they have planned to receive an investigational agent or vaccine before the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination Timepoints:15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period Timepoints:Day 1 (2 months of age) to 18 months of age ; Outcome name: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. Measure:Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination Timepoints:15 minutes to Day 7 ; Outcome name: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. Measure:Numero de sujetos que informaron eventos adversos no solicitados despues de cualquier vacunacion Timepoints:Dia 1 (2 meses de edad) a 18 meses de edad | — |
Countries
China, Costa Rica, Guatemala, Panama, Peru, Puerto Rico, Taiwan, United States
Contacts
Public ContactElizabeth Beatriz Rospigliosi
I3 LATIN AMERICA PERU S.A.
Outcome results
None listed