HealthyPhase 2NCT00381615

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

A Phase 2 study testing rMenB, rMenB+OMV and DTaP-Hib-IPV in people with Healthy, run by Novartis Vaccines at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants. Read more about this study

Who is it for?: Ages 55 to 89 daysHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: rMenB, rMenB+OMV and DTaP-Hib-IPV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 3 sitesUnited Kingdom
Study dates: Sep 2006to Aug 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects eligible to be enrolled in the study:
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

Who cannot join

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):
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.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

Study site
Gloucester, GLI 3NN
Study site
London, NW9 5EQ
Study site
Oxford, OX3 7LJ

Other trials in United Kingdom

About this 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

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

Conditions: Healthy
Being tested: rMenB, rMenB+OMV, DTaP-Hib-IPV, PC7, MenC-CRM
Keywords: Meningococcal disease, prevention, vaccination
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rMenBBiological
Also called Serogroup B meningococcal recombinant vaccine without OMV-NZ
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
rMenB+OMVBiological
Also called Serogroup B meningococcal recombinant vaccine with OMV-NZ
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
DTaP-Hib-IPVBiological
Also called Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B, and inactivated polio vaccine; Pediacel
Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
PC7Biological
Also called Heptavalent Streptoccus pneumonia vaccine; Prevenar
IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
MenC-CRMBiological
Also called CRM197 conjugated meningococcal C vaccine; Menjugate
MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.
MenC-HibBiological
Also called Combined meningococcal C and Haemophilus influenzae type B vaccine; Menitorix
MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.
MMRBiological
Also called Measles, mumps, and rubella vaccine; Priorix
IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.

Study groups in NCT00381615
Study group	Role	What they receive
rMenB	Experimental	Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without outer membrane vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of Diphtheria Tetanus Pertussis-Haemophilus influenzae type b-Inactivated Polio Vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months). Receives: Biological: rMenB; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MenC-CRM; Biological: MenC-Hib; Biological: MMR
rMenB+OMV	Experimental	Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Receives: Biological: rMenB+OMV; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MenC-CRM; Biological: MenC-Hib; Biological: MMR
Routine	Experimental	Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. Receives: Biological: rMenB; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MenC-CRM; Biological: MenC-Hib; Biological: MMR
Routine+OMV	Experimental	Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. Receives: Biological: rMenB+OMV; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MenC-CRM; Biological: MenC-Hib; Biological: MMR

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Measured: 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
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Measured: 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
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).
Measured: Day 1 through day 7 after each vaccination
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).
Measured: 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
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).
Measured: 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
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).
Measured: Day 1 through day 7 after each vaccination
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).
Measured: Day 1 through day 7 after each vaccination
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.
Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.
Measured: 30 days after the third vaccination
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.
Measured: At baseline (pre-vaccination) and 30 days after the third vaccination

Secondary outcomes (8)

Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.
Measured: 1 month after first vaccination
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
Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.
Measured: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination
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
Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.
Measured: pre-first vaccination and 1 month after first vaccination
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
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.
Measured: 30 days after the second vaccination and 1 month after fourth (booster) vaccination
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.
Measured: pre-first vaccination and 1 month after first vaccination
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
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.
Measured: 1 month after first vaccination
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.
Measured: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.
Measured: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Aug 2008

First posted28 Sep 2006 (estimated)
Study startSep 2006
Primary completionJul 2007
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00381615
Sponsor's protocol ID: V72P6
Status last verified: Sep 2015
First submitted: 27 Sep 2006
Last updated: 9 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00381615
Acronym / sponsor ID: V72P6
Conditions: Healthy
Keywords: Meningococcal disease, prevention, vaccination
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jul 2007 (actual)
Study completion: Aug 2008 (actual)
First posted: 28 Sep 2006 (estimated)
Results: Posted 9 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
rMenB	Experimental	Biological: rMenB, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MenC-CRM, Biological: MenC-Hib, Biological: MMRInfants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without outer membrane vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of Diphtheria Tetanus Pertussis-Haemophilus influenzae type b-Inactivated Polio Vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months).
rMenB+OMV	Experimental	Biological: rMenB+OMV, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MenC-CRM, Biological: MenC-Hib, Biological: MMRInfants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Routine	Experimental	Biological: rMenB, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MenC-CRM, Biological: MenC-Hib, Biological: MMRInfants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
Routine+OMV	Experimental	Biological: rMenB+OMV, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MenC-CRM, Biological: MenC-Hib, Biological: MMRInfants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.

Who may qualify

Ages: 55 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (5 listed)

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):
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rMenBAlso: Serogroup B meningococcal recombinant vaccine without OMV-NZOne dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.	Biological	Routine, rMenB
rMenB+OMVAlso: Serogroup B meningococcal recombinant vaccine with OMV-NZOne dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.	Biological	Routine+OMV, rMenB+OMV
DTaP-Hib-IPVAlso: Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B, and inactivated polio vaccine; PediacelIntramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.	Biological	Routine, Routine+OMV, rMenB, rMenB+OMV
PC7Also: Heptavalent Streptoccus pneumonia vaccine; PrevenarIM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.	Biological	Routine, Routine+OMV, rMenB, rMenB+OMV
MenC-CRMAlso: CRM197 conjugated meningococcal C vaccine; MenjugateMenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.	Biological	Routine, Routine+OMV, rMenB, rMenB+OMV
MenC-HibAlso: Combined meningococcal C and Haemophilus influenzae type B vaccine; MenitorixMenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.	Biological	Routine, Routine+OMV, rMenB, rMenB+OMV
MMRAlso: Measles, mumps, and rubella vaccine; PriorixIM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.	Biological	Routine, Routine+OMV, rMenB, rMenB+OMV

Primary outcome

Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Time frame: Baseline and one month after third-dose of infants series
Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Time frame: Baseline and one month after third-dose of infants series
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Time frame: Day 1 through day 7 after each vaccination
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Time frame: Day 1 through day 7 after each vaccination
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Time frame: Day 1 through day 7 after each vaccination
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Time frame: Day 1 through day 7 after each vaccination
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Time frame: Day 1 through day 7 after each vaccination
Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).
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.
Time frame: 30 days after the third vaccination
Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Time frame: At baseline (pre-vaccination) and 30 days after the third vaccination
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.

8 secondary outcomes

Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
Time frame: 1 month after first vaccination
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
Time frame: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination
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
Time frame: pre-first vaccination and 1 month after first vaccination
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
Time frame: 30 days after the second vaccination and 1 month after fourth (booster) vaccination
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
Time frame: pre-first vaccination and 1 month after first vaccination
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
Time frame: 1 month after first vaccination
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Time frame: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Time frame: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.

Results and safety

Results posted to the registry on 9 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rMenB	48	44
rMenB+OMV	50	45
Routine	25	24
Routine+OMV	24	22

Primary outcome: Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization

Time frame: Baseline and one month after third-dose of infants series. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	rMenB n = 46	rMenB+OMV n = 46
Strain 44/76-SL - Titer ≥1:4 - Baseline	11 (4 to 24)	11 (4 to 24)
Str. 44/76-SL-Titer ≥1:4- Post-3rd dose (N=36,39)	78 (61 to 90)	87 (73 to 96)
Strain 5/99 - Titer ≥1:4 - Baseline (N=42,43)	7 (1 to 19)	14 (5 to 28)
Str. 5/99 - Titer ≥1:4- Post-3rd dose (N=32,37)	100 (89 to 100)	95 (82 to 99)
Strain NZ98/254 - Titer ≥1:4 - Baseline (N=46,46)	4 (1 to 15)	9 (2 to 21)
Str. NZ98/254-Titer ≥1:4- Post-3rd dose (N=37,40)	5 (1 to 18)	85 (70 to 94)

Population analysed: Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.

Primary outcome: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ

Time frame: Baseline and one month after third-dose of infants series. Geometric mean (95% Confidence Interval). Unit: titers

Measure	rMenB n = 46	rMenB+OMV n = 46
Strain 44/76-SL - Baseline	1.32 (1.05 to 1.66)	1.4 (1.16 to 1.69)
Strain 44/76-SL - Post-3rd dose (N=36,39)	13 (8.11 to 22)	30 (19 to 46)
Strain 5/99 - Baseline (N=42,43)	1.22 (0.98 to 1.52)	1.43 (1.12 to 1.81)
Strain 5/99 - Post-3rd dose (N=32,37)	159 (100 to 253)	126 (77 to 205)
Strain NZ98/254 - Baseline (N=46,46)	1.23 (1 to 1.52)	1.15 (1.02 to 1.29)
Strain NZ98/254 - Post-3rd dose (N=37,40)	1.16 (0.98 to 1.38)	19 (11 to 33)

Population analysed: Analysis was performed on the PP set.

Primary outcome: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV

Time frame: Day 1 through day 7 after each vaccination. Number. Unit: Number of subjects

Measure	rMenB n = 48	rMenB+OMV n = 50	Routine n = 24	Routine+OMV n = 23
Tenderness - Vaccination 1	17	17	0	0
Tenderness - Vaccination 2 (N=48,48,24,23)	10	14	0	0
Tenderness - Vaccination 3 (N=47,48,24,23)	10	17	6	7
Tenderness - Vaccination 4 (N=45,48,24,23)	10	23	0	0
Erythema - Vaccination 1	40	42	0	0
Erythema - Vaccination 2 (N=48,48,24,23)	43	45	0	0
Erythema - Vaccination 3 (N=47,48,24,23)	43	44	0	0
Erythema - Vaccination 4 (N=45,48,24,23)	43	46	0	0

Population analysed: Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.

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

Time frame: Day 1 through day 7 after each vaccination. Number. Unit: Number of subjects

Measure	rMenB n = 48	rMenB+OMV n = 50	Routine n = 25	Routine+OMV n = 24
Tenderness - Vaccination 1	19	21	7	10
Tenderness - Vaccination 3 (N=48,48,25,24)	10	12	6	6
Erythema - Vaccination 1	38	43	24	20
Erythema - Vaccination 3 (N=48,48,25,24)	43	42	24	22
Induration - Vaccination 1	19	21	11	13
Induration - Vaccination 3 (N=48,48,25,24)	19	19	13	16

Population analysed: Analysis was performed on the safety set.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB	3 of 48 (6.3%)	48 of 48 (100%)	Not reported
rMenB+OMV	9 of 50 (18%)	50 of 50 (100%)	Not reported
Routine	4 of 25 (16%)	25 of 25 (100%)	Not reported
Routine+OMV	2 of 24 (8.3%)	24 of 24 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines - Information Services study chair

Novartis

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rMenB, rMenB+OMV and DTaP-Hib-IPV in people with Healthy, run by Novartis Vaccines at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization (time frame: Baseline and one month after third-dose of infants series). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00381615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.