Who is sponsoring NCT02639351?

NCT02639351 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02639351?

Interventions in NCT02639351: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R, Investigational MenC-CRM adjuavnted with 50 ug of LHD153R, Investigational MenC-CRM adjuavnted with 100 ug of LHD153R, Meningococcal C-CRM Conjugate Vaccine (MenC-CRM).

What condition does NCT02639351 study?

NCT02639351 studies Infections, Meningococcal.

Is NCT02639351 still recruiting?

NCT02639351 is currently completed. Last updated 28 June 2019.

Are results published for NCT02639351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-28 · How we verify

NCT02639351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 28 June 2019

What this trial tests

Phase 1 trial testing Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R in Infections, Meningococcal in 80 participants. Completed in 31 August 2017.

Timeline

1 March 2016

Primary endpoint
31 August 2017

31 August 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	80
Start date	1 March 2016
Primary completion	31 August 2017
Estimated completion	31 August 2017
Sites	1 location across Germany

Drugs / interventions tested

Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R — full drug profile →
Investigational MenC-CRM adjuavnted with 25 ug of LHD153R — full drug profile →
Investigational MenC-CRM adjuavnted with 50 ug of LHD153R — full drug profile →
Investigational MenC-CRM adjuavnted with 100 ug of LHD153R — full drug profile →
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM) — full drug profile →

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Infections, Meningococcal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Primary · Within 30 minutes of vaccination (Min) at Day 1

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom rega

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	1
MenC Group	0

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	1
MenC Group	1

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Number of Subjects With Any Solicited Local and Systemic AEs Primary · From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: A

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	16
LHD153R Formulation 2 Group	16
LHD153R Formulation 3 Group	16
LHD153R Formulation 4 Group	16
MenC Group	16

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	4
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	2
MenC Group	0

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	2
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	3
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	3
LHD153R Formulation 4 Group	5
MenC Group	3

Number of Subjects With Any Solicited Local and Systemic AEs Primary · From Day 5 to Day 8

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	16
LHD153R Formulation 2 Group	16
LHD153R Formulation 3 Group	16
LHD153R Formulation 4 Group	16
MenC Group	16

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	2
MenC Group	0

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	1
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	4
MenC Group	0

Number of Subjects With Any Solicited Local and Systemic AEs Primary · From Day 8 to Day 14

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: A

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	16
LHD153R Formulation 2 Group	16
LHD153R Formulation 3 Group	16
LHD153R Formulation 4 Group	16
MenC Group	16

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	2
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	2
MenC Group	0

Number of Subjects With Any Solicited Local and Systemic AEs Primary · From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: A

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	16
LHD153R Formulation 2 Group	16
LHD153R Formulation 3 Group	16
LHD153R Formulation 4 Group	16
MenC Group	16

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	4
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	4
MenC Group	0

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	3
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	3
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	3
LHD153R Formulation 4 Group	6
MenC Group	3

Number of Subjects With Any Solicited Local and Systemic AEs Primary · From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: A

Any Erythema

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Induration

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Pain

Group	Value	95% CI
LHD153R Formulation 1 Group	16
LHD153R Formulation 2 Group	16
LHD153R Formulation 3 Group	16
LHD153R Formulation 4 Group	16
MenC Group	16

Any Swelling

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any Arthralgia

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	4
MenC Group	0

Any Chills

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	1
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	4
MenC Group	0

Any Diarrhea

Group	Value	95% CI
LHD153R Formulation 1 Group	1
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	3
MenC Group	0

Any Fatigue

Group	Value	95% CI
LHD153R Formulation 1 Group	3
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	3
LHD153R Formulation 4 Group	6
MenC Group	3

Number of Subjects With Any Unsolicited AEs Primary · From Day 1 to Day 29

An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-

Group	Value	95% CI
LHD153R Formulation 1 Group	4
LHD153R Formulation 2 Group	2
LHD153R Formulation 3 Group	1
LHD153R Formulation 4 Group	4
MenC Group	4

Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Primary · From Day 1 to Day 366

SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important \& significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedD

Any SAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	1

Any MAAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	6
LHD153R Formulation 2 Group	9
LHD153R Formulation 3 Group	5
LHD153R Formulation 4 Group	8
MenC Group	8

Any AEs leading to withdrawal

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any NOCDs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any AESIs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Primary · From Day 1 to Day 29

SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of sp

Any SAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any MAAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	2
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	3
MenC Group	0

Any AEs leading to withdrawal

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any NOCDs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any AESIs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Primary · From Day 29 up to study end (Day 366)

Any SAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	1

Any MAAEs

Group	Value	95% CI
LHD153R Formulation 1 Group	5
LHD153R Formulation 2 Group	9
LHD153R Formulation 3 Group	5
LHD153R Formulation 4 Group	5
MenC Group	8

Any AEs leading to withdrawal

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any NOCDs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Any AESIs

Group	Value	95% CI
LHD153R Formulation 1 Group	0
LHD153R Formulation 2 Group	0
LHD153R Formulation 3 Group	0
LHD153R Formulation 4 Group	0
MenC Group	0

Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. Primary · At Day 1 (pre-dose)

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).

Group	Value	95% CI
LHD153R Formulation 1 Group	138.07	± 1.226
LHD153R Formulation 2 Group	136.77	± 1.514
LHD153R Formulation 3 Group	136.73	± 1.891
LHD153R Formulation 4 Group	138.29	± 1.875
MenC Group	137.06	± 1.821

Group	Value	95% CI
LHD153R Formulation 1 Group	4.253	± 0.325
LHD153R Formulation 2 Group	4.176	± 0.162
LHD153R Formulation 3 Group	4.185	± 0.346
LHD153R Formulation 4 Group	3.962	± 0.178
MenC Group	4.253	± 0.253

Group	Value	95% CI
LHD153R Formulation 1 Group	104.25	± 1.382
LHD153R Formulation 2 Group	103.94	± 2.057
LHD153R Formulation 3 Group	103.91	± 1.973
LHD153R Formulation 4 Group	104.99	± 2.168
MenC Group	104.03	± 2.120

BUN

Group	Value	95% CI
LHD153R Formulation 1 Group	4.545	± 1.085
LHD153R Formulation 2 Group	5.048	± 1.422
LHD153R Formulation 3 Group	5.247	± 1.039
LHD153R Formulation 4 Group	4.616	± 0.930
MenC Group	4.606	± 1.327

Bicarbonate

Group	Value	95% CI
LHD153R Formulation 1 Group	25.42	± 1.638
LHD153R Formulation 2 Group	25.75	± 1.293
LHD153R Formulation 3 Group	27.09	± 2.180
LHD153R Formulation 4 Group	26.64	± 1.944
MenC Group	25.98	± 1.749

Changes in Clinical Serum Chemistry Parameters Primary · At Day 1 (post-dose)

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Group	Value	95% CI
LHD153R Formulation 1 Group	-0.34	± 1.051
LHD153R Formulation 2 Group	0.45	± 1.693
LHD153R Formulation 3 Group	-0.33	± 2.097
LHD153R Formulation 4 Group	-0.86	± 1.744
MenC Group	-0.09	± 2.020

Group	Value	95% CI
LHD153R Formulation 1 Group	0.002	± 0.361
LHD153R Formulation 2 Group	0.043	± 0.205
LHD153R Formulation 3 Group	0.100	± 0.310
LHD153R Formulation 4 Group	0.028	± 0.208
MenC Group	0.178	± 0.254

Group	Value	95% CI
LHD153R Formulation 1 Group	-0.55	± 1.526
LHD153R Formulation 2 Group	-0.32	± 2.005
LHD153R Formulation 3 Group	-0.74	± 2.080
LHD153R Formulation 4 Group	-1.06	± 2.828
MenC Group	-0.10	± 2.122

BUN

Group	Value	95% CI
LHD153R Formulation 1 Group	-0.209	± 0.944
LHD153R Formulation 2 Group	-0.911	± 0.838
LHD153R Formulation 3 Group	-0.949	± 0.940
LHD153R Formulation 4 Group	-0.556	± 0.493
MenC Group	-0.433	± 0.616

Bicarbonate

Group	Value	95% CI
LHD153R Formulation 1 Group	0.09	± 1.080
LHD153R Formulation 2 Group	0.51	± 1.381
LHD153R Formulation 3 Group	0.88	± 1.690
LHD153R Formulation 4 Group	0.41	± 1.413
MenC Group	0.66	± 1.733

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LHD153R Formulation 1 Group

Serious: 0/16 (0%)

Deaths: 0/16

LHD153R Formulation 2 Group

Serious: 0/16 (0%)

Deaths: 0/16

LHD153R Formulation 3 Group

Serious: 0/16 (0%)

Deaths: 0/16

LHD153R Formulation 4 Group

Serious: 0/16 (0%)

Deaths: 0/16

MenC Group

Serious: 1/16 (6%)

Deaths: 0/16

Serious adverse events (1 terms)

Reaction	System	LHD153R Formulation 1 Group	LHD153R Formulation 2 Group	LHD153R Formulation 3 Group	LHD153R Formulation 4 Group	MenC Group
Joint injury	Injury, poisoning and procedural complications	—	—	—	—	—

Other adverse events (54 terms — click to expand)

Reaction	System	LHD153R Formulation 1 Group	LHD153R Formulation 2 Group	LHD153R Formulation 3 Group	LHD153R Formulation 4 Group	MenC Group
Pain	General disorders	—	—	—	—	—
Headache	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Myalgia	General disorders	—	—	—	—	—
Arthralgia	General disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Loss of Appetite	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Diarrhea	General disorders	—	—	—	—	—
Nausea	General disorders	—	—	—	—	—
Swelling	General disorders	—	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Vomiting	General disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Gastroenteritis norovirus	Infections and infestations	—	—	—	—	—
Herpes virus infection	Infections and infestations	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Tinea pedis	Infections and infestations	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Induration	General disorders	—	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—	—
Joint injury	Injury, poisoning and procedural complications	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—
Sunburn	Injury, poisoning and procedural complications	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Exostosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Most-reported serious reactions: Joint injury.

Data from ClinicalTrials.gov NCT02639351 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine.
Gonzalez-Lopez A, Oostendorp J, Koernicke T, Fadini T, et al · · 2019 · cited 18× · PMID 31669193 · DOI 10.1016/j.clim.2019.108275
Advances in vaccine adjuvant development and future perspectives.
Sinani G, Şenel S. · · 2025 · cited 10× · PMID 40536024 · DOI 10.1080/10717544.2025.2517137
Systems analysis of human responses to an aluminium hydroxide-adsorbed TLR7 agonist (AS37) adjuvanted vaccine reveals a dose-dependent and specific activation of the interferon-mediated antiviral response.
Siena E, Schiavetti F, Borgogni E, Taccone M, et al · · 2023 · cited 10× · PMID 36564274 · DOI 10.1016/j.vaccine.2022.12.006
Therapeutic Cancer Vaccines-Antigen Discovery and Adjuvant Delivery Platforms.
Alarcon NO, Jaramillo M, Mansour HM, Sun B. · · 2022 · cited 10× · PMID 35890342 · DOI 10.3390/pharmaceutics14071448

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02639351 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 28 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02639351.

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NCT02639351

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other GlaxoSmithKline trials

Verify against primary sources