Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study (NCT00381615) | Clinical Trial Compass
CompletedPhase 2
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
United Kingdom147 participantsStarted 2006-09
Plain-language summary
This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
Who can participate
Age range55 Days – 89 Days
SexALL
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Inclusion criteria
✓. 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;
✓. for whom a parent/legal guardian had provided written informed consent after the nature of the study had been explained;
✓. those available for all the visits scheduled in the study;
✓. those in good health as determined by:
✓. medical history
✓. physical examination
✓. clinical judgment of the investigator
Exclusion criteria
✕. receipt of any immunosuppressive therapy since birth
✕. receipt of immunostimulants since birth
✕. 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.
What they're measuring
1
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
2
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
3
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
4
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Timeframe: Day 1 through day 7 after each vaccination
5
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
6
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
7
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
8
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
9
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