Trial Outcomes & Findings for Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults (NCT NCT00772629)

Last Updated: 2014-02-14

Results Overview

Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2014-02-14

Participant Flow

Participants were recruited from 26 January to 29 April 2004 at 2 Medical clinics in the United Kingdom

Eighteen (18) participants that met the inclusion and exclusion criteria were enrolled. One whom no baseline blood sample could be obtained at Visit 1 was not vaccinated and withdrew from the study.

Participant milestones

Participant milestones
Measure	Meningococcal Vaccine-naive Group Participants have never received any meningococcal vaccine in the past	Meningococcal Vaccine-primed Group Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
Overall Study STARTED	17	1
Overall Study COMPLETED	16	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Meningococcal Vaccine-naive Group Participants have never received any meningococcal vaccine in the past	Meningococcal Vaccine-primed Group Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
Overall Study Subject was not vaccinated	1	0

Baseline Characteristics

Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meningococcal Vaccine-naive Group n=17 Participants Participants have never received any meningococcal vaccine in the past	Meningococcal Vaccine-primed Group n=1 Participants Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	1 Participants n=4 Participants	18 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	35.8 Years STANDARD_DEVIATION 10.20 • n=93 Participants	43.0 Years STANDARD_DEVIATION 0 • n=4 Participants	36.2 Years STANDARD_DEVIATION 10.03 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	0 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United Kingdom	17 participants n=93 Participants	1 participants n=4 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.

Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.

Outcome measures

Outcome measures
Measure	Meningococcal Vaccine-naive Group n=16 Participants Participants have never received any meningococcal vaccine in the past	Meningococcal Vaccine-primed Group n=1 Participants Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. Meningococcal serogroup A	14 Participants	0 Participants
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. Meningococcal serogroup C	11 Participants	0 Participants
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. Meningococcal serogroup Y	14 Participants	1 Participants
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. Meningococcal serogroup W-135	15 Participants	0 Participants

Adverse Events

Meningococcal Vaccine-naive Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Meningococcal Vaccine-primed Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Meningococcal Vaccine-naive Group n=16 participants at risk Participants have never received any meningococcal vaccine in the past	Meningococcal Vaccine-primed Group n=1 participants at risk Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
General disorders Chest pain	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Infections and infestations Cellulitis	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Infections and infestations Nasopharyngitis	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Infections and infestations Tinea pedis	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Infections and infestations Upper respiratory tract infection NOS	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Infections and infestations Viral infection NOS	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Nervous system disorders Headache	12.5% 2/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma NOS	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Skin and subcutaneous tissue disorders Paronychia	6.2% 1/16 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.	0.00% 0/1 • Adverse events data were collected from the day of vaccination for 42 days post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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