AzTrials
AzTrials

Meningococcal DiseasePhase 2/3NCT00944034

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

A Phase 2/3 study testing rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ and two doses of rMenB+OMV NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 72 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months… Read more about this study

Who is it for?
Ages 12 to 24 monthsHealthy volunteers can take part
What is being tested?
rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ and two doses of rMenB+OMV NZ
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,588 participants
Where
72 sitesin 6 countries
Study dates
Jul 2009to Jan 2012
Phase
Phase 2/3
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 12 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Follow-on participants of V72P12:
  • Healthy toddlers who completed Study V72P12, aged:
  • 12 months or older - Groups 1a, 2a, 3a, 4
  • 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
  • 24 months (0/ +29 days window) - Groups 1c, 2c, 3c
  • Naive subjects newly enrolled:
  • Group 5: healthy 18-month-old toddlers (0/ +29 days window)
  • Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Who cannot join

  • History of any meningococcal B vaccine administration (only for groups 5 and 6);
  • 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 to 38 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.

Trial locations and contacts

72 sites in 6 countries.

72 sites in 6 countries

Germany30 sites

  • Study site

    Ahrensböker Str. 11, 23617 Stockelsdorf

  • Study site

    Am Alten Hafen 117, 27568 Bremerhaven

  • Study site

    Ammertalweg 7, 99086 Erfurt

  • Study site

    Anne Frank Str.27, 75015 Bretten

  • Study site

    Bucher Chaussee 1-3, 13125 Berlin

  • Study site

    Christian-Bauer-Str.5, 73642 Welzheim

  • Study site

    Deckertstr. 53, 33645 Bielefeld

  • Study site

    Dingbängerweg 69, 48163 Münster

  • Study site

    Elisenstr. 28, 63739 Aschaffenburg

  • Study site

    Gartenstr. 3,76889 Schweigen

  • Study site

    Großbottwarer Str. 47, 71720 Oberstenfeld

  • Study site

    Hanseatenplatz 1, 25524 Itzehoe

  • Study site

    Hauptstr. 165, 42579 Heiligenhaus

  • Study site

    Hauptstr. 240, 77694 Kehl

  • Study site

    Hauptstr. 46, 37083 Göttingen

  • Study site

    Josef-Sugg-Str. 5, 88348 Bad Saulgau

  • Study site

    Kapellenstraße 27, 47533 Kleve-Materborn

  • Study site

    Kleinenbroicher Str. 68, 41352 Korschenbroich

  • Study site

    Kuhtrift 8a, 34414 Warburg

  • Study site

    Langenbeckstraße 1, 55101 Mainz

  • Study site

    Lindenpromenade 34b, 39164 Wanzleben

  • Study site

    Lindenstr. 9, 25524 Itzehoe

  • Study site

    Marienstraße 2, 44866 Bochum

  • Study site

    Maschstr. 8a, 49565 Bramsche

  • Study site

    Mose-Stern-Str. 28, 41236 Mönchengladbach

  • Study site

    Ostlandstr. 10, 32339 Espelkamp

  • Study site

    Poststr. 10, 34225 Baunatal

  • Study site

    Tangstedter Landstr 77, 22415 Hamburg

  • Study site

    Wilhelmshöher Allee 109, 34121 Kassel

  • Study site

    Würzburger Str. 1, 97941 Tauberbischofsheim

Other trials in Germany

Spain16 sites

  • Study site

    Avda. Rambleta, S/n Catarroja Valencia

  • Study site

    C/ Tossal Del Rei Nº 7 Castellón de La Plana Castellón

  • Study site

    Catarroja Esquina Ministro Serrano. Paiporta Valencia

  • Study site

    Celestino Villamil, S/n Oviedo

  • Study site

    Ctra. Anfondeguilla, S/n Vall Duixo Castellón

  • Study site

    Isabel de Villena,2 Pabellón Valencia

  • Study site

    Médico Fernando Moray de La Horra, 2 Acceso Y9 Valencia

  • Study site

    Molí S/n Puçol Valencia

  • Study site

    Pedro S/n Almazora Castellón

  • Study site

    Pizarro, 22 Vigo Pontevedra

  • Study site

    Plaza Blasco Ibañez, 4 Sagunto Valencia

  • Study site

    Plaza Segovia S/n Valencia

  • Study site

    República Argentina Nº 8, Valencia

  • Study site

    Rosales, 23 La Eliana Valencia

  • Study site

    Serreria,73 Valencia

  • Study site

    Travesía Da Choupana, S/n Santiago de Compostela A Coruña

Other trials in Spain

Italy10 sites

  • Study site

    C.so Mazzini 18, 28100 Novar

  • Study site

    Current Address: Via Luca Giordano N. 13, 50132 Firenze

  • Study site

    Piazza Ospedale 10, 20900 Lodi

  • Study site

    Via Commenda 9, 20122, Milano

  • Study site

    Via Consolare Valeria 1, 98125 Messina

  • Study site

    Via G.B.Grossi 74, 20157 Milano

  • Study site

    Via Giustiniani,3, 35128 Padova

  • Study site

    Via Pastore 1,16132 Genova

  • Study site

    Via Siracusa, 45, 90143 Palermo

  • Study site

    Viale Pieraccini N. 24 50139 Firenze

Other trials in Italy

Belgium7 sites

  • Study site

    Avenue Albert 1er 185, 5000 Namur

  • Study site

    Avenue Hippocrate 10, 1200 Brussels

  • Study site

    Laarbeeklaan 101, 1090 Brussels

  • Study site

    Lindendreef 1, 2020 Antwerpen

  • Study site

    Sint Vincentiusstraat 20, 2018 Antwerpen

  • Study site

    Stadsomvaart 11, 3500 Hasselt

  • Study site

    Wilrijkstraat 10, 2650 Edegem

Other trials in Belgium

United Kingdom5 sites

  • South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust

    Barrack Road, Exeter, EX2 5DW

  • St. George's University of London

    Cranmer Terrace, London, SW17 0RE

  • Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road

    Headington, Oxford, OX3 7LJ

  • University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters

    Marlborough Street, Bristol, BS1 3NU

  • Centre for Clinical Vaccinology

    Oxford, OX3 7LJ

Other trials in United Kingdom

Czechia4 sites

  • Study site

    Červený Kostelec, 549 41

  • Study site

    Kyjevska 44, 532 03 Pardubice

  • Study site

    Ruskych Legii 352, 377 01 Jindrichuv Hradec

  • Study site

    Trebesska 1575, 500 01 Hradec Kralove

Other trials in Czechia

About this study

Official title: A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

Being tested
rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ, two doses of rMenB+OMV NZ
Keywords
Meningococcal meningitis, prevention, vaccination, toddler
Medical subject headings
Meningococcal Infections, Meningitis, Meningococcal

What participants receive

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

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

  • rMenB+OMV NZBiological

    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

  • rMenB+OMV NZBiological

    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age

  • two doses of rMenB+OMV NZBiological

    two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

  • two doses of rMenB+OMV NZBiological

    two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age

  • rMenB+OMV NZBiological

    rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

  • two doses of rMenB+OMV NZBiological

    two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age

  • rMenB+OMV NZ with routine vaccinationsBiological

    rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age

Study groups in NCT00944034
Study groupRoleWhat they receive
B+R246_12ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B+R246_18ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B+R246_24ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B246_12ExperimentalPreviously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Receives: Biological: rMenB+OMV NZ
B246_18ExperimentalPreviously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Receives: Biological: rMenB+OMV NZ
B246_24ExperimentalPreviously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Receives: Biological: rMenB+OMV NZ
B+R234_12ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B+R234_18ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B+R234_24ExperimentalPreviously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Receives: Biological: rMenB+OMV NZ with routine vaccinations
B12 14ExperimentalPreviously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Receives: Biological: two doses of rMenB+OMV NZ
B18 20ExperimentalPreviously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Receives: Biological: two doses of rMenB+OMV NZ
B24 26ExperimentalPreviously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Receives: Biological: two doses of rMenB+OMV NZ

What is being measured

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

  1. Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.

    Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.

    Measured: 1 month after booster

Secondary outcomes (10)

  1. Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.

    Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.

    Measured: 1 month after booster

  2. Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.

    Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.

    Measured: 1 month after booster

  3. Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.

    The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

    Measured: 1 month after booster

  4. GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age

    Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

    Measured: 1 month after booster

  5. GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age

    Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

    Measured: 1 month after booster

  6. Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months

    Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

    Measured: 1 month after second vaccination

  7. Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.

    Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.

    Measured: 1 month after booster vaccination

  8. Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.

    Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA

    Measured: 1 month after booster vaccination

  9. Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

    The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.

    Measured: From day 1 to day 7 after vaccination

  10. Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

    The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.

    Measured: day 1 to day 7 after vaccination

Timeline

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

  1. First posted22 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2011
  4. Study completionJan 2012

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00944034
Sponsor's protocol ID
V72P12E1
Other IDs
2009-011676-30, 2009
Status last verified
Jul 2017
First submitted
21 Jul 2009
Last updated
14 Aug 2017

Publications

  • Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.

    PubMed 33020485

  • Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, Dull PM, Kohl I, Barone M, Wang H, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016 Apr;35(4):e113-23. doi: 10.1097/INF.0000000000001056.

    PubMed 26756390

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ and two doses of rMenB+OMV NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 72 sites in 6 countries.

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 8 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Germany, Spain, Italy, Belgium, United Kingdom and 1 more country. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Nov 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?

Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age. (time frame: 1 month after booster). 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 NCT00944034, which also lists 2 linked publications.

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 14 Aug 2017.

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