CompletedPhase 2

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Belgium1,885 participantsStarted 2008-08

Plain-language summary

Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.

Who can participate

Age range55 Days – 89 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; * For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained. Exclusion Criteria: * History of any meningococcal B or C vaccine administration; * prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens); * Previous ascertained or suspected disease caused by N. meningitidis; * History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day; * Antibiotics within 6 days prior to enrollment; * Any serious chronic or progressive disease; * Known or suspected impairment or alteration of the immune system; * Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.

What they're measuring

Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine

Timeframe: One month after third Men B vaccination

Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age

Timeframe: 10 months (groups 1 and 2); 8 months (groups 3 and 4)

Trial details

NCT IDNCT00721396

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

Results submitted2015-02-18

View on ClinicalTrials.gov More Meningococcal Infections trials