A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Disease

Treatments: Biological: HBV; Biological: MenACWY-CRM; Biological: DTaP-IPV/Hib; Biological: MMR; Biological: PCV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000311

V59_33

Details and patient eligibility

About

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

Enrollment: 529 patients

Sex: All

Ages: 55 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg.

2. Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.

3. Parent/legal representative was available for all visits scheduled in the study.

4. Subjects were in good health as determined by:

   1. medical history
   2. physical assessment
   3. clinical judgment of the investigator

Exclusion criteria

1. Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
2. Subjects who had 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).
3. Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5. Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
6. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
7. Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
8. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
9. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
10. Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
12. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subjects who 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.
14. Subjects who were relatives of site research staff working on this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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529 participants in 2 patient groups

MenACWY-CRM + Routine Vaccines

Experimental group

Description:

Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.

Treatment:

Biological: PCV

Biological: MenACWY-CRM

Biological: MMR

Biological: DTaP-IPV/Hib

Biological: HBV

Routine Vaccines

Experimental group

Description:

Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months. In addition subjects were offered a dose of MenACWY-CRM at 18 months as a benefit of participating in this study. However, blood was not drawn for immunogenicity analysis after this dose.

Treatment:

Biological: PCV

Biological: MMR

Biological: DTaP-IPV/Hib

Biological: HBV