Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: MenACWY-CRM197; DTaP (Diptheria, Tetanus, Pertussis) Vaccine; Hib (Haemophilus influenza b) Vaccine; IPV (Inactivated Polio Vaccine) Vaccine; Pneumococcal conjugate Vaccine; MMR (Measles, Mumps, and Rubella) Vaccine; Varicella Vaccine; Hepatitis A Virus
Intervention description: Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.; Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.; Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.; Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.; Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.; One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.; One vaccination of Varicella vaccine was administered at 12 months of age.; One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7744.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; infants; healthy; meningitis; meningococcal

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
    

Eligibility criteria:

        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.