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 range

55 Days – 89 Days

Sex

ALL

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), 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7

Timeframe: Day 1 through day 7 after each vaccination

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

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

Trial details

NCT IDNCT00381615

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07

Results submitted2015-02-04

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

55 Days – 89 Days

Sex

ALL

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), 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

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

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

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

Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7

Timeframe: Day 1 through day 7 after each vaccination

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

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