Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments meningoccal b recombinant vaccine together with routine vaccines: dtap-ipv-hib, hepb, pcv (2-4-6 months of age) and mmrv (12 months of age), routine vaccines: dtap-ipv-hib, hepb, pcv (2-4-6 months of age) and mmrv (12 months of age)
Phase phase 3
Sponsor Novartis
Collaborator Novartis Vaccines
Start date September 2014
End date December 2015
Trial size 225 participants
Trial identifier NCT02173704, V72_60

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
rMeMenB+OMV NZ together with routine vaccines
meningoccal b recombinant vaccine together with routine vaccines: dtap-ipv-hib, hepb, pcv (2-4-6 months of age) and mmrv (12 months of age)
Meningococcal B recombinant vaccine + DTaP-IPV-Hib, HepB, PCV (2-4-6 months of age) and MMRV (12 months of age)
(Active Comparator)
routine vaccines
routine vaccines: dtap-ipv-hib, hepb, pcv (2-4-6 months of age) and mmrv (12 months of age)
DTaP-IPV-Hib, HepB, PCV (2-4-6 months of age) and MMRV (12 months of age)

Primary Outcomes

Measure
Immunogenicity: percentage of subjects with SBA titer higher than or equal to 1:5
time frame: 1 month following the third Vaccination
Safety: assess percentage and numbers of subjects with local and systemic adverse events
time frame: Until Day 7 post-each vaccination
Safety: percentage of subjects with SAEs, medically attended AEs and AEs leading to study withdrawal
time frame: Until study end (at 13 months of age)

Secondary Outcomes

Measure
Percentage of subjects with SBA titer higher than or equal to 1:5
time frame: 1 month following the booster
SBA GMTs
time frame: Baseline (2 months of age), 1 month after the third vaccination (7 months of age), prior to the booster vaccination (12 months of age), 1 month after the booster vaccination (13 months of age)
SBA GMRs
time frame: 1 month after the third vaccination (7 months of age), prior to the booster vaccination (12 months of age), 1 month after the booster vaccination (13 months of age) to Baseline (2 months of age)

Eligibility Criteria

Male or female participants from 55 days up to 89 days old.

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.

Additional Information

Official title A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants in Taiwan.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Novartis.