Last updated: 04/10/2025 06:40:21
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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Care Provider)
Allocation:
Randomized
Primary outcomes:
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
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:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Timeframe: From Day 1 to Day 7 after vaccination
Numbers of Subjects With Other Unsolicited AEs
Timeframe: Day 8 After vaccination Through Study Termination, up to 6 months
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Timeframe: From Day 1 to Day 7 after vaccination
Interventions:
Biological/vaccine: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
Biological/vaccine: Tdap
Enrollment:
440
Observational study model:
Not applicable
Primary completion date:
2012-23-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2011 to July 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 18 Years
Accepts healthy volunteers
Yes
- 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;
- 1. History of any meningococcal vaccine administration;
- 2. Current or previous, confirmed or suspected disease caused by N meningitidis;
Inclusion and exclusion 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.
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2012-23-01
Actual study completion date
2012-06-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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