Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    v72p12

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00944034
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : November 10, 2015
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief 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 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.

Condition or disease Intervention/treatment Phase
Meningococcal Disease Meningococcal Meningitis Biological: rMenB+OMV NZ with routine vaccinations Biological: rMenB+OMV NZ Biological: two doses of rMenB+OMV NZ Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Experimental: B+R246_12
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B+R246_18
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B+R246_24
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B246_12
Previously 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.
Biological: rMenB+OMV NZ
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

Experimental: B246_18
Previously 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.
Biological: rMenB+OMV NZ
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

Experimental: B246_24
Previously 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.
Biological: rMenB+OMV NZ
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

Experimental: B+R234_12
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B+R234_18
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B+R234_24
Previously 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.
Biological: rMenB+OMV NZ with routine vaccinations
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

Experimental: B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Biological: two doses of rMenB+OMV NZ
two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.

Experimental: B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Biological: two doses of rMenB+OMV NZ
two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age

Experimental: B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Biological: two doses of rMenB+OMV NZ
two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age




Primary Outcome Measures :
  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. [ Time Frame: 1 month after booster ]
    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.


Secondary Outcome Measures :
  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. [ Time Frame: 1 month after booster ]
    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.

  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. [ Time Frame: 1 month after booster ]
    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.

  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. [ Time Frame: 1 month after booster ]
    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.

  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 [ Time Frame: 1 month after booster ]
    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.

  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 [ Time Frame: 1 month after booster ]
    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.

  6. Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months [ Time Frame: 1 month after second vaccination ]
    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.

  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. [ Time Frame: 1 month after booster vaccination ]
    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.

  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. [ Time Frame: 1 month after booster vaccination ]
    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

  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. [ Time Frame: From day 1 to day 7 after vaccination ]
    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.

  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. [ Time Frame: day 1 to day 7 after vaccination ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944034


Locations
Hide Hide 72 study locations
Layout table for location information
Belgium
Avenue Albert 1er 185, 5000 Namur, Belgium
Avenue Hippocrate 10, 1200 Brussels, Belgium
Laarbeeklaan 101, 1090 Brussels, Belgium
Lindendreef 1, 2020 Antwerpen, Belgium
Sint Vincentiusstraat 20, 2018 Antwerpen, Belgium
Stadsomvaart 11, 3500 Hasselt, Belgium
Wilrijkstraat 10, 2650 Edegem, Belgium
Czechia
Cerveny Kostelec, Czechia, 549 41
Kyjevska 44, 532 03 Pardubice, Czechia
Ruskych legii 352, 377 01 Jindrichuv Hradec, Czechia
Trebesska 1575, 500 01 Hradec Kralove, Czechia
Germany
Ahrensböker Str. 11, 23617 Stockelsdorf, Germany
Am Alten Hafen 117, 27568 Bremerhaven, Germany
Ammertalweg 7, 99086 Erfurt, Germany
Anne Frank Str.27, 75015 Bretten, Germany
Bucher Chaussee 1-3, 13125 Berlin, Germany
Christian-Bauer-Str.5, 73642 Welzheim, Germany
Deckertstr. 53, 33645 Bielefeld, Germany
Dingbängerweg 69, 48163 Münster, Germany
Elisenstr. 28, 63739 Aschaffenburg, Germany
Gartenstr. 3,76889 Schweigen, Germany
Großbottwarer Str. 47, 71720 Oberstenfeld, Germany
Hanseatenplatz 1, 25524 Itzehoe, Germany
Hauptstr. 165, 42579 Heiligenhaus, Germany
Hauptstr. 240, 77694 Kehl, Germany
Hauptstr. 46, 37083 Göttingen, Germany
Josef-Sugg-Str. 5, 88348 Bad Saulgau, Germany
Kapellenstraße 27, 47533 Kleve-Materborn, Germany
Kleinenbroicher Str. 68, 41352 Korschenbroich, Germany
Kuhtrift 8a, 34414 Warburg, Germany
Langenbeckstraße 1, 55101 Mainz, Germany
Lindenpromenade 34b, 39164 Wanzleben, Germany
Lindenstr. 9, 25524 Itzehoe, Germany
Marienstraße 2, 44866 Bochum, Germany
Maschstr. 8a, 49565 Bramsche, Germany
Mose-Stern-Str. 28, 41236 Mönchengladbach, Germany
Ostlandstr. 10, 32339 Espelkamp, Germany
Poststr. 10, 34225 Baunatal, Germany
Tangstedter Landstr 77, 22415 Hamburg, Germany
Wilhelmshöher Allee 109, 34121 Kassel, Germany
Würzburger Str. 1, 97941 Tauberbischofsheim, Germany
Italy
C.so Mazzini 18, 28100 Novar, Italy
Current address: Via Luca Giordano n. 13, 50132 Firenze, Italy
Piazza Ospedale 10, 20900 Lodi, Italy
Via Commenda 9, 20122, Milano, Italy
Via Consolare Valeria 1, 98125 Messina, Italy
Via G.B.Grossi 74, 20157 Milano, Italy
Via Giustiniani,3, 35128 Padova, Italy
Via Pastore 1,16132 Genova, Italy
Via Siracusa, 45, 90143 Palermo, Italy
Viale Pieraccini n. 24 50139 Firenze, Italy
Spain
Avda. Rambleta, s/n Catarroja Valencia, Spain
C/ Tossal del Rei nº 7 Castellón de la Plana Castellón, Spain
Catarroja Esquina Ministro Serrano. Paiporta Valencia, Spain
Celestino Villamil, s/n Oviedo, Spain
Ctra. Anfondeguilla, s/n Vall Duixo Castellón, Spain
Isabel de Villena,2 Pabellón Valencia, Spain
Molí s/n Puçol Valencia, Spain
Médico Fernando Moray de la Horra, 2 acceso Y9 Valencia, Spain
Pedro s/n Almazora Castellón, Spain
Pizarro, 22 Vigo Pontevedra, Spain
Plaza Blasco Ibañez, 4 Sagunto Valencia, Spain
Plaza Segovia s/n Valencia, Spain
República Argentina nº 8, Valencia, Spain
Rosales, 23 La Eliana Valencia, Spain
Serreria,73 Valencia, Spain
Travesía da Choupana, s/n Santiago de Compostela A Coruña, Spain
United Kingdom
University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters
Marlborough Street, Bristol, United Kingdom, BS1 3NU
South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust
Barrack Road, Exeter, United Kingdom, EX2 5DW
St. George's University of London
Cranmer Terrace, London, United Kingdom, SW17 0RE
Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Headington, Oxford, United Kingdom, OX3 7LJ
Centre for Clinical Vaccinology
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
GlaxoSmithKline

Layout table for additonal information
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00944034    
Other Study ID Numbers: V72P12E1
2009-011676-30
First Posted: July 22, 2009    Key Record Dates
Results First Posted: November 10, 2015
Last Update Posted: August 14, 2017
Last Verified: July 2017
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal meningitis
prevention
vaccination
toddler
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs