Clinical trial NCT00381615: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official title: A Phase 2, Open Label, Multi-Center, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine±OMV, When Administered to Healthy Infants at 2, 4, 6 and/or 12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Meningococcal disease
prevention
vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 147
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.


Eligibility criteria: Inclusion Criteria:

Subjects eligible to be enrolled in the study:

1. healthy 2-month old infants (55-89 days, inclusive), 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 had provided written informed consent after the nature of the study had been explained;
3. those available for all the visits scheduled in the study;
4. those in good health as determined by:

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

Exclusion Criteria:

Individuals were not to be enrolled into the study:

1. whose parents/legal guardians were unwilling or unable to give written informed consent to participate in the study; 2. who had previously received any meningococcal B vaccine; 3. who had received prior vaccination with Diphtheria Tetanus Pertussis (DTP) (acellular or whole cell), Inactivated Polio Vaccine (IPV) or Oral Polio Vaccine (OPV), H influenzae type b (Hib) or Heptavalent Pneumococcal Conjugate (PC7) vaccine; 4. who had a previous ascertained or suspected disease caused by N meningitidis, S pneumoniae, C diphtheriae, tetani, Poliovirus, Hib, or B pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period ≥2weeks associated with apnea or whooping); 5. who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis, B pertussis, Hib, C diphtheriae or Polio infection since birth; 6. who had a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 7. who had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (≥38.0°C) within the previous 3 days; 8. who had any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome); 9. who had leukemia, lymphomas; 10. who had a known or suspected autoimmune disease or impairment/alteration of immune function resulting from (for example):

1. receipt of any immunosuppressive therapy since birth
2. receipt of immunostimulants since birth
3. receipt of any systemic corticosteroid since birth 11. with a suspected or known HIV infection or HIV related disease; 12. who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation from birth and for the full length of the study; 13. with a known bleeding diathesis, or any condition that might be associated with a prolonged bleeding time; 14. who had experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome 15. who had taken antibiotics within 7 days prior to enrollment (exception: antibiotics taken once daily within 14 days after the last dose); 16. who had either received, or for whom there was intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period; 17. who had ever received another investigational agent from birth prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study; 18. whose parents/legal guardians, were planning to leave the area of the study site before the end of the study period; 19. with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
timeFrame: Baseline and one month after third-dose of infants series
measure: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
timeFrame: Baseline and one month after third-dose of infants series
measure: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
timeFrame: Day 1 through day 7 after each vaccination
measure: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
timeFrame: Day 1 through day 7 after each vaccination
measure: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
timeFrame: Day 1 through day 7 after each vaccination
measure: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
timeFrame: Day 1 through day 7 after each vaccination
measure: Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
timeFrame: Day 1 through day 7 after each vaccination
measure: Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.
timeFrame: 30 days after the third vaccination
measure: Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
timeFrame: At baseline (pre-vaccination) and 30 days after the third vaccination
Secondary outcomes:
measure: Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
timeFrame: 1 month after first vaccination
measure: Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
timeFrame: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination
measure: Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
timeFrame: pre-first vaccination and 1 month after first vaccination
measure: Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
timeFrame: 30 days after the second vaccination and 1 month after fourth (booster) vaccination
measure: Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
timeFrame: pre-first vaccination and 1 month after first vaccination
measure: Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age
timeFrame: 1 month after first vaccination
measure: Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
timeFrame: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.
measure: Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
timeFrame: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
city: London
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Information Services
role: STUDY_CHAIR
References: