louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01466192: Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
Official title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Genotype 2
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.


Eligibility criteria: Inclusion Criteria:

* Genotype 2, chronic hepatitis C
* Relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia,; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18.
Clinical trial NCT00914992: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Official title: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: optic disk
regional blood flow
autoregulation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve head (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure. The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments are designed to improve the investigators' knowledge of the physiology of regulatory mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow abnormalities in glaucoma. This is of importance, because there is increasing evidence that vascular dysregulation plays a role in the development of glaucomatous damage.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases

Primary outcomes:
measure: Ocular perfusion pressure - ONH blood flow relationship
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Elzbieta Polska, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03217292: Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Official title: Evaluation of the Effect of Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, single-blind
Primary purpose: TREATMENT

Brief summary: Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the prevention of postoperative pulmonary complications.Various regional methods of anesthesia are currently being used to achieve this goal. The aim of the study was to assess the effectiveness of SAPB on postoperative VATS analgesia.


Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: tramadol consumption
timeFrame: Postoperative 24 hour
measure: Ramsay sedation scale (RSS)
timeFrame: 24 hours
Other outcomes:
measure: side effect profile
timeFrame: 24 hours
measure: additional analgesic use
timeFrame: 24 hours
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Burcu Metin Ökmen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04007692: Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation
Official title: Suturing Pattern for Endolumenal Stenting Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Stenosis
Stent Migration
Suture, Complication
Keywords: Esophageal stenosis
Endoscopic suturing
Esophageal stent fixation
Stent migration
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-vulnerable adults who are receiving an endoscopically placed esophageal stent for any indication at Mayo Clinic Rochester.

Brief summary: Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.

Detailed description: The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 or above
* Subjects undergoing esophageal stent placement with any indication

Exclusion Criteria:

* Imprisoned individuals,
* Institutionalized patients
* Inability or unwillingness of individual

Primary outcomes:
measure: Stent migration rate
timeFrame: 4 weeks post stent placement
measure: Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barham K Abu Dayyeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144192: Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Official title: Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).


Eligibility criteria: Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam
* Be at least 18 years of age to 65 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Exclusion Criteria:

* Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication
* Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation
* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization

Primary outcomes:
measure: Peak plasma concentration (Cmax) of lidocaine
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TKL Research, Inc.
name: Phillip LaStella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.
Clinical trial NCT02767492: Steroid Injection vs. BioDRestore for Patients With Knee OA
Official title: A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2016-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 80 years.
* Willing and able to give voluntary informed consent to participate in this investigation.
* Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
* Candidate for intra-articular knee injection.
* BMI \< 40

Exclusion Criteria:

* Patients who have received intra-articular injection(s) in the last 3 months.
* Patients who have undergone arthroscopic surgery on the study knee in the past year.
* Patients who have undergone arthroplasty on the study knee.
* Ligament instability
* Diabetes (Type 1 or II)
* Inflammatory arthropathies.
* Fibromyalgia or chronic fatigue syndrome.
* Female patient who is pregnant or nursing.
* Chronic use of narcotics.
* Any other reason (in the judgment of the investigator).

Primary outcomes:
measure: Visual Analog Pain Score
timeFrame: Surgery through 12 months post-op/
measure: Veterans Rand 12 Item Health Survey
timeFrame: Sugery to 12 months post-op
measure: Lysholm Knee Score
timeFrame: Surgery to 12 months post-op.
measure: Single Alpha Numeric Evaluation (SANE)
timeFrame: Surgery to 12 months post-op.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Surgery to 12 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
name: Paul Siffri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882592: Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Official title: Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cerebral Palsy
Lead sponsor: SpineX Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy


Eligibility criteria: Inclusion Criteria:

* 1) individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries.

Exclusion Criteria:

* Intramuscular Botox injection in the past 12 months

Primary outcomes:
measure: Stepping overground or on a treadmill
timeFrame: 3 months
measure: Gross Motor Functional Measure (GMFM)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: SpineX
state: California
Study officials:
References:
Clinical trial NCT05545592: Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer
Official title: A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: FET
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 660
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.

Detailed description: According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).

Eligibility criteria: Inclusion Criteria:

1. Female;
2. Aged between 20 and 40 years old;
3. Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
4. Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
5. The total number of transfer cycles was \< 3;
6. Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with chromosomal abnormalities;
2. Contraindications to hormone replacement therapy;
3. Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
4. Participating in other clinical studies.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 45 days after embryo transfer
Secondary outcomes:
measure: Embryo implantation rate
timeFrame: 45 days after embryo transfer
measure: Early pregnancy loss rate
timeFrame: 12 weeks after embryo transfer
measure: Incidence of thrombosis
timeFrame: 12 weeks after embryo transfer
measure: Incidence rate of gestational hypertension
timeFrame: 45 weeks after embryo transfer
measure: Premature birth rate
timeFrame: 41 weeks after embryo transfer
measure: Proportion of low birth weight infants
timeFrame: 41 weeks after embryo transfer
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT03843892: An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
Official title: Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-02-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.


Eligibility criteria: Inclusion Criteria:

None

Exclusion Criteria:

- Patients who are eligible for and can participate in an ongoing non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) study will be excluded from participation in this Expanded Access Program (EAP).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center Tucson
state: Arizona
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Bedford
country: United States
facility: Centra Medical Group
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
References:
Clinical trial NCT00346892: To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
Official title: Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rotavirus Infections
Keywords: Prophylaxis rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 450
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: "The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.

The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."

Detailed description: The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV + DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before the 2002 RV season were to receive two doses of HRV or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 RV season received vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI vaccinations were to be administered concomitantly with the study vaccines.

Eligibility criteria: Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.

Primary outcomes:
measure: Seroprotection for each polio serotype 1 month after the 3rd dose.
Secondary outcomes:
measure: Proportion of subjects with vaccine take 1 month after each dose of study vaccine, viral shedding in a subset of subjects, presence of RV in diarrheal stools, anti-rota IgA antibody seroconversion rate and serum anti-rota IgA antibody concent
Other outcomes:
Locations:
city: Pretoria
country: South Africa
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: