CompletedPhase 3

Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Austria3,630 participantsStarted 2008-03

Plain-language summary

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.

Who can participate

Age range55 Days – 89 Days

SexALL

See this in plain English?

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) Exclusion Criteria: * 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; * Any serious chronic or progressive disease * Known or suspected impairment or alteration of the immune system

What they're measuring

The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination

Timeframe: one month after the third vaccination

The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)

Timeframe: one month after the third vaccination

Trial details

NCT IDNCT00657709

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2015-02-13

View on ClinicalTrials.gov More Serogroup B Meningococcal Meningitis trials