NCT01165229 is a Phase 3 clinical trial of Herpes Zoster Vaccine GSK1437173A in Herpes Zoster, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01165229?

NCT01165229 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01165229?

Interventions in NCT01165229: Herpes Zoster Vaccine GSK1437173A, Placebo.

What condition does NCT01165229 study?

NCT01165229 studies Herpes Zoster, Herpes Zoster Vaccine.

Is NCT01165229 still recruiting?

NCT01165229 is currently completed. Last updated 27 April 2020.

Are results published for NCT01165229?

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

Last reviewed 2020-04-27 · How we verify

NCT01165229

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

Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

Completed Phase 3 Results posted Last updated 27 April 2020

What this trial tests

Phase 3 trial testing Herpes Zoster Vaccine GSK1437173A in Herpes Zoster in 14,819 participants. Completed in 24 July 2015.

Timeline

2 August 2010

Primary endpoint
24 July 2015

24 July 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	14,819
Start date	2 August 2010
Primary completion	24 July 2015
Estimated completion	24 July 2015
Sites	213 locations across France, Hong Kong, Finland, Italy, Japan, Sweden, Taiwan, Estonia

Drugs / interventions tested

Herpes Zoster Vaccine GSK1437173A — full drug profile →
Placebo

Conditions studied

Herpes Zoster — all drugs for Herpes Zoster →
Herpes Zoster Vaccine — all drugs for Herpes Zoster Vaccine →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

70 and older, any sex, with Herpes Zoster or Herpes Zoster Vaccine. 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 Episodes of Herpes Zoster (HZ) Primary · During the entire study period (3 to 5 year period following Day 0)

Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	17
Zoster-022 GSK1437173A >=80YOA Group	6
Zoster-022 GSK1437173A >=70YOA Group	23
Zoster-022 Placebo 70-79YOA Group	169
Zoster-022 Placebo >=80YOA Group	54
Zoster-022 Placebo >=70YOA Group	223

Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) Primary · During the entire study period (3 to 5 year period following Day 0)

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

Group	Value	95% CI
Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	2
Zoster-022/006 Pooled GSK1437173A >=80YOA Group	2
Zoster-022/006 Pooled GSK1437173A >=70YOA Group	4
Zoster-022/006 Pooled Placebo 70-79YOA Group	29
Zoster-022/006 Pooled Placebo >=80YOA Group	7
Zoster-022/006 Pooled Placebo >=70YOA Group	36

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ Primary · During the entire study period (3 to 5 year period following Day 0)

Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.

Group	Value	95% CI
Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	19
Zoster-022/006 Pooled GSK1437173A >=80YOA Group	6
Zoster-022/006 Pooled GSK1437173A >=70YOA Group	25
Zoster-022/006 Pooled Placebo 70-79YOA Group	216
Zoster-022/006 Pooled Placebo >=80YOA Group	68
Zoster-022/006 Pooled Placebo >=70YOA Group	284

Number of Subjects With Post-herpetic Neuralgia (PHN) Secondary · During the entire study period (3 to 5 year period following Day 0)

PHN cases in the mTVc.

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	2
Zoster-022 GSK1437173A >=80YOA Group	2
Zoster-022 GSK1437173A >=70YOA Group	4
Zoster-022 Placebo 70-79YOA Group	22
Zoster-022 Placebo >=80YOA Group	6
Zoster-022 Placebo >=70YOA Group	28

Number of Days With Severe 'Worst' HZ-associated Pain Secondary · During the entire study period (3 to 5 year period following Day 0)

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	21.8	± 31.41
Zoster-022 GSK1437173A >=80YOA Group	98.7	± 57.73
Zoster-022 GSK1437173A >=70YOA Group	34.6	± 45.54
Zoster-022 Placebo 70-79YOA Group	47.9	± 100.08
Zoster-022 Placebo >=80YOA Group	50.4	± 106.51
Zoster-022 Placebo >=70YOA Group	48.5	± 101.40

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Secondary · During the entire study period (3 to 5 year period following Day 0)

The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

Mortality

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	0

Hospitalization

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	3
Zoster-022 Placebo >=80YOA Group	2
Zoster-022 Placebo >=70YOA Group	5

Mortality or hospitalization

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	3
Zoster-022 Placebo >=80YOA Group	2
Zoster-022 Placebo >=70YOA Group	5

Number of Subjects With Overall Mortality and HZ-related Mortality Secondary · During the entire study period (3 to 5 year period following Day 0)

The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	0

Number of Subjects With Confirmed HZ Episode Related Hospitalizations Secondary · During the entire study period (3 to 5 year period following Day 0)

Incidence of overall and HZ-related hospitalizations during the study.

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	3
Zoster-022 Placebo >=80YOA Group	2
Zoster-022 Placebo >=70YOA Group	5

Number of Subjects With HZ Related Complications Secondary · During the entire study period (3 to 5 year period following Day 0)

Incidence of HZ complications during the study in subjects with confirmed HZ.

At least one complication

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	1
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	1
Zoster-022 Placebo 70-79YOA Group	6
Zoster-022 Placebo >=80YOA Group	4
Zoster-022 Placebo >=70YOA Group	10

HZ vasculitis

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	0

Disseminated Disease

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	2
Zoster-022 Placebo >=70YOA Group	2

Ophthalmic Disease

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	1
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	1
Zoster-022 Placebo 70-79YOA Group	4
Zoster-022 Placebo >=80YOA Group	2
Zoster-022 Placebo >=70YOA Group	6

Neurologic Disease

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	3
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	3

Visceral Disease

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	0

Stroke

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	0
Zoster-022 Placebo 70-79YOA Group	0
Zoster-022 Placebo >=80YOA Group	0
Zoster-022 Placebo >=70YOA Group	0

Number of Subjects Receiving Pain Medication Associated With HZ Secondary · During the entire study period (3 to 5 year period following Day 0)

Incidence of use of pain medications throughout the study

At least 1 pain medication

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	7
Zoster-022 GSK1437173A >=80YOA Group	3
Zoster-022 GSK1437173A >=70YOA Group	10
Zoster-022 Placebo 70-79YOA Group	123
Zoster-022 Placebo >=80YOA Group	37
Zoster-022 Placebo >=70YOA Group	160

1 pain medication only

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	5
Zoster-022 GSK1437173A >=80YOA Group	0
Zoster-022 GSK1437173A >=70YOA Group	5
Zoster-022 Placebo 70-79YOA Group	43
Zoster-022 Placebo >=80YOA Group	17
Zoster-022 Placebo >=70YOA Group	60

2 pain medications only

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	0
Zoster-022 GSK1437173A >=80YOA Group	1
Zoster-022 GSK1437173A >=70YOA Group	1
Zoster-022 Placebo 70-79YOA Group	30
Zoster-022 Placebo >=80YOA Group	4
Zoster-022 Placebo >=70YOA Group	34

3 pain medications or more

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	2
Zoster-022 GSK1437173A >=80YOA Group	2
Zoster-022 GSK1437173A >=70YOA Group	4
Zoster-022 Placebo 70-79YOA Group	50
Zoster-022 Placebo >=80YOA Group	16
Zoster-022 Placebo >=70YOA Group	66

Number of Days With Pain Medication Associated With HZ Secondary · During the entire study period (3 to 5 year period following Day 0)

Incidence of reduction of duration of pain medication associated with HZ throughout the study.

Group	Value	95% CI
Zoster-022 GSK1437173A 70-79YOA Group	38.7	± 56.44
Zoster-022 GSK1437173A >=80YOA Group	274.7	± 337.00
Zoster-022 GSK1437173A >=70YOA Group	109.5	± 200.88
Zoster-022 Placebo 70-79YOA Group	218.6	± 593.80
Zoster-022 Placebo >=80YOA Group	135.0	± 207.31
Zoster-022 Placebo >=70YOA Group	199.3	± 530.60

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Secondary · Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Any Pain, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	297
Zoster-022 Placebo Group	26

Grade 3 Pain, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	12
Zoster-022 Placebo Group	1

Any Redness, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	143
Zoster-022 Placebo Group	3

Grade 3 Redness, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	9
Zoster-022 Placebo Group	0

Any Swelling, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	85
Zoster-022 Placebo Group	2

Grade 3 Swelling, Dose 1

Group	Value	95% CI
Zoster-022 GSK1437173A Group	2
Zoster-022 Placebo Group	0

Any Pain, Dose 2

Group	Value	95% CI
Zoster-022 GSK1437173A Group	282
Zoster-022 Placebo Group	23

Grade 3 Pain, Dose 2

Group	Value	95% CI
Zoster-022 GSK1437173A Group	12
Zoster-022 Placebo Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: within 7 days (Days 0-6) after vaccination; Unsolicited adverse events: within 30 days (Days 0-29) after vaccination; Serious Adverse Events (SAEs): during the entire study period (3 to 5 year period following Day 0).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zoster-022 GSK1437173A Group

Serious: 1153/6950 (17%)

Deaths: 426/6950

Zoster-022 Placebo Group

Serious: 1214/6950 (17%)

Deaths: 459/6950

Serious adverse events (955 terms)

Reaction	System	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Pneumonia	Infections and infestations	—	—
Cardiac failure	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Death	General disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Cardiac arrest	Cardiac disorders	—	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Chest pain	General disorders	—	—
Syncope	Nervous system disorders	—	—
Transient ischaemic attack	Nervous system disorders	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Cerebral infarction	Nervous system disorders	—	—
Myocardial ischaemia	Cardiac disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Injection site pain	General disorders	—	—
Injection site erythema	General disorders	—	—
Injection site swelling	General disorders	—	—
Headache	Nervous system disorders	—	—
Pyrexia	General disorders	—	—
Fatigue	General disorders	—	—
Pain	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Chills	General disorders	—	—

Most-reported serious reactions: Pneumonia, Cardiac failure, Atrial fibrillation, Myocardial infarction, Cerebrovascular accident, Cardiac failure congestive, Death, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT01165229 adverse events section.

Sponsor's own description

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

Publications & conference data

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

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older.
Cunningham AL, Lal H, Kovac M, Chlibek R, et al · · 2016 · cited 740× · PMID 27626517 · DOI 10.1056/nejmoa1603800
Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.
Cunningham AL, Heineman TC, Lal H, Godeaux O, et al · · 2018 · cited 153× · PMID 29529222 · DOI 10.1093/infdis/jiy095
Impact of disease-modifying antirheumatic drugs on vaccine immunogenicity in patients with inflammatory rheumatic and musculoskeletal diseases.
Friedman MA, Curtis JR, Winthrop KL. · · 2021 · cited 93× · PMID 34493491 · DOI 10.1136/annrheumdis-2021-221244
Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination.
Strezova A, Diez-Domingo J, Al Shawafi K, Tinoco JC, et al · · 2022 · cited 80× · PMID 36299530 · DOI 10.1093/ofid/ofac485
The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70.
Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, et al · · 2022 · cited 77× · PMID 34283213 · DOI 10.1093/cid/ciab629
Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials.
López-Fauqued M, Campora L, Delannois F, El Idrissi M, et al · · 2019 · cited 53× · PMID 30935742 · DOI 10.1016/j.vaccine.2019.03.043
Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults.
Schwarz TF, Volpe S, Catteau G, Chlibek R, et al · · 2018 · cited 50× · PMID 29461919 · DOI 10.1080/21645515.2018.1442162
Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.
Dagnew AF, Rausch D, Hervé C, Zahaf T, et al · · 2021 · cited 47× · PMID 32910152 · DOI 10.1093/rheumatology/keaa424

Verify or expand the search:

Other trials of Herpes Zoster Vaccine GSK1437173A

Trials testing the same drug.

NCT02723773 — A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy · Phase 3 · completed
NCT02735915 — Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years · Phase 3 · completed
NCT02690207 — Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previou · Phase 3 · completed
NCT01165203 — Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subj · Phase 2 · completed
NCT01165177 — Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adul · Phase 3 · completed

Other recruiting trials for Herpes Zoster

Currently open trials in the same condition.

NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · recruiting
NCT07307170 — The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster · NA · recruiting
NCT07293065 — A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell) · Phase 3 · active not recruiting
NCT07361796 — The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes · NA · recruiting
NCT07378046 — The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster · NA · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

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 NCT01165229 (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: 27 April 2020

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/NCT01165229.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing