Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal; Meningococcal Disease

Treatments: Biological: Routine vaccines; Biological: Bexsero®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173704

2014-005568-14 (EudraCT Number)

205249

V72_60 (Other Identifier)

Details and patient eligibility

About

Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.

Enrollment: 225 patients

Sex: All

Ages: 55 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
3. available for all the visits scheduled in the study;
4. in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

1. History of any meningococcal vaccine administration;
2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), Pneumococcal, MMR or varicella antigens;
3. Previous ascertained or suspected disease caused by N. meningitidis;
4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
6. Significant acute or chronic infection within the previous 7 days or body temperature higher or equal to 38C degrees within the previous day;
7. Antibiotics within 6 days prior to enrollment;
8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth;
10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of rotavirus vaccine, influenza vaccine and second HepB vaccine), within 28 days prior and throughout the study period. Furthermore, subjects must have received HepB vaccine preferably at 0, 1 month of age, with the second dose at least 14 days prior to study vaccination. Influenza vaccine should be administered at least 14 days before or 14 days after study vaccination; Rotavirus vaccine may be administered during the study as per local practice.
12. Participation in another clinical trial since birth or planned for during study;
13. Family members and household members of research staff;
14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Bexsero + Routine Group

Experimental group

Description:

Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.

Treatment:

Biological: Bexsero®

Routine Group

Active Comparator group

Description:

Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.

Treatment:

Biological: Routine vaccines