Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Infections, Meningococcal

Treatments: Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153R; Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM); Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153R; Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153R; Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R

Study type: Interventional

Funder types: Industry

Identifiers

NCT02639351

V132_01EXP (Other Identifier)

205496

2014-002430-31 (EudraCT Number)

Details and patient eligibility

About

Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).

Enrollment: 80 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female individuals of 18 through 45 years of age on the day of informed consent
2. Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
4. Individuals who can comply with study procedures including follow-up
5. Individuals that are able to understand, read and write German language
6. Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.

Exclusion criteria

1. Progressive, unstable or uncontrolled clinical conditions
2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
4. Abnormal function of the immune system
5. Received immunoglobulins or any blood products within 180 days prior to informed consent
6. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
7. Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
8. Any relevant deviation from the laboratory parameters at screening as judged by the investigator
9. Previously received any vaccine that included a MenC antigen
10. Previously suspected or confirmed disease caused by N. meningitides
11. Had household contact with and/or intimate exposure to an individual with culture proven MenC
12. A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
13. A positive drugs-of-abuse test prior to the study vaccine administration;
14. Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
15. Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 5 patient groups

LHD153R Formulation 1 Group

Experimental group

Description:

Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R.

Treatment:

Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R

LHD153R Formulation 2 Group

Experimental group

Description:

Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R.

Treatment:

Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153R

LHD153R Formulation 3 Group

Experimental group

Description:

Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R.

Treatment:

Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153R

LHD153R Formulation 4 Group

Experimental group

Description:

Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.

Treatment:

Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153R

MenC Group

Active Comparator group

Description:

Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.

Treatment:

Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)