Clinical trial NCT01367158: Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
Official title: Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal disease
vaccines
adolescents
prevention
Meningitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 440
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.


Eligibility criteria: Inclusion Criteria:

Individuals eligible to be enrolled into this study were male or female who completed study V102_02 (primary study), and:

1. who were 11 to 18 years at the time of enrollment in primary study;
2. who had given their written consent at the time of enrollment;
3. who were available for all the visits scheduled in the study (ie, not planning to leave the area before the end of the study period);
4. who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

1. History of any meningococcal vaccine administration;
2. Current or previous, confirmed or suspected disease caused by N meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N meningitidis infection within 60 days of enrollment;
4. Significant acute or chronic infection within the previous 7 days or fever (defined as temperature \>38°C) within the previous 3 days;
5. Antibiotics within 7 days prior to enrollment or blood draw;
6. Pregnancy or nursing (breastfeeding) mothers;
7. Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide); intrauterine device or sexual abstinence was considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
8. Any serious chronic or progressive disease (eg, neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure or severe malnutrition).
9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids or immunostimulants within the previous 60 days. Use of topical corticosteroids administered during the study in limited areas (ie, eczema on knees or face or elbows) of the body was allowed;
10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
12. Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 4 weeks from the study vaccines.
13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or had intent to participate in another clinical study at any time during the conduct of this study.
14. Individuals who were part of study personnel or close family members conducting this study.
15. Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or posed additional risk to the subjects due to participation in the study.

Primary outcomes:
measure: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 6 and month 7
measure: Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 6 and month 7
Secondary outcomes:
measure: Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 6 and month 7
measure: Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 7
measure: GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 6 and month 7
measure: GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 7
measure: Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 7
measure: Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
timeFrame: At month 7
measure: GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
timeFrame: At month 1, 3, 6, 7 and 12
measure: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
timeFrame: From Day 1 to Day 7 after vaccination
measure: Numbers of Subjects With Other Unsolicited AEs
timeFrame: Day 8 After vaccination Through Study Termination, up to 6 months
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
timeFrame: From Day 1 to Day 7 after vaccination
Other outcomes:
Locations:
city: Aurora de Chile 9872 - San Ramón
country: Chile
facility: CESFAM Gabriela Mistral:
state: Saniago
city: Marcoleta 350
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Santiago
city: Avenida Carrera 68# 90-88 Piso 4
country: Colombia
facility: CAFAM
state: Bogota
city: Carrera 14 No. 94-49 PisoSexto
country: Colombia
facility: Centro de Investigacion CafeSalud Medicina Prepagada
state: Bogota
city: Carrera
country: Colombia
facility: CAIMED
state: Bogotá
city: Clayton, ciudad del Saber Edificio 219
country: Panama
facility: Indicasat:
state: Panama City
city: Piso numero 5, Consultorio 12; Via Espana, las Sabanas,
country: Panama
facility: Health Research International: Centro Especializado san Fernando
state: Panama city
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Saez-Llorens X, Aguilera Vaca DC, Abarca K, Maho E, Han L, Smolenov I, Dull P. Persistence of Meningococcal Antibodies and Response to a Third Dose After a Two-dose Vaccination Series with Investigational MenABCWY Vaccine Formulations in Adolescents. Pediatr Infect Dis J. 2015 Oct;34(10):e264-78. doi: 10.1097/INF.0000000000000822.